Health
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.
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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.
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.”
“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)
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.”
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At the hearing, Mercer said there were “quite a few large veteran organizations that shared the great need for a solution to PTSD.”
“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.”
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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.”
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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.
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.
“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.”
Over the two and a half years following the 2022 rollout of the 988 national suicide prevention hotline, the rate of suicides among young people in the United States dropped 11 percent below projections, decreasing most sharply in states with a higher volume of answered 988 calls, a new study has found.
The findings, published today as a research letter in JAMA, compared suicide deaths from July 2022 to December 2024 with sophisticated mathematical projections that were based on historical trends. This yielded good news, with 4,372 fewer suicides of adolescents and young adults, ages 15 to 34, than had been projected.
To ensure that the decline was related to the use of the hotline, researchers at Harvard Medical School teased out the trends in states with high and low usage of the hotline. The findings were striking: The 10 states with the largest increases in 988 calls experienced an 18.2 percent reduction in observed suicides compared with expected suicides; in the 10 states with the lowest uptake, the reduction was smaller, 10.6 percent.
The results suggest that the government’s investment in the 988 rollout has translated into “a measurable reduction of deaths,” said Dr. Vishal Patel, a resident physician at Brigham and Women’s Hospital and one of the authors of the study.
“What our study has added,” he said, “is evidence for the deeper benefit of the program, and that is, that at the population level, among young people at least, suicide mortality is lower than it would have been without the program.”
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Are you concerned for your teen? If you worry that your teen might be experiencing depression or suicidal thoughts, there are a few things you can do to help. Dr. Christine Moutier, the chief medical officer of the American Foundation for Suicide Prevention, suggests these steps:
He added, “The implication of that is that sustained funding for this program matters.”
The United States rolled out the three-digit hotline with bipartisan support in July 2022, replacing a 10-digit hotline number, and augmented it with a $1.5 billion investment in crisis center capacity. Since its inception, the service has fielded more than 25 million contacts, according to the Department of Health and Human Services. The agency has asked Congress for $534.6 million to fund the program for 2027.
Last summer, the Trump administration terminated one element of the hotline, the Press 3 option for L.G.B.T.Q.+ callers. The Substance Abuse and Mental Health Services Administration said that the Press 3 option was being discontinued because it had exhausted its funding from Congress and that the hotline would “focus on serving all help seekers.”
But advocacy groups and policymakers protested the decision, and in testimony before the Senate on Tuesday, the health secretary, Robert F. Kennedy Jr., said his agency was planning to restore the Press 3 option.
Dr. Patel said his group had become curious about measuring the program’s effectiveness after Press 3 was eliminated. While call volume and satisfaction surveys suggested that 988 was succeeding, he said, the harder question was, “Did the creation of this 988 program, the transition from the old hotline to this hotline, actually move the needle on suicide mortality?”
Experts said it was difficult to tease out the beneficial effect of 988 from other things that changed in 2022, the year that the new hotline was created. Around that time, suicide prevention programs were being introduced in schools, in faith communities and on social media, but more important, the pandemic was ending.
“We were finally out of this crazy time, and there was a sense of optimism and hope,” said Jonathan B. Singer, a professor of social work at Loyola University Chicago and a co-author of “Suicide in Schools.” He called the downward trend in youth suicides “encouraging, but it is tempered by the fact that we don’t have a good explanation as to why.”
The authors acknowledged that their findings could not account for the influence of social and economic changes, changes in mental health services or public awareness about services.
But they did make comparisons to exclude other possible explanations. The authors looked for similar effects among American adults over 65, who are less likely to use the hotline. In that group, there was a reduction in suicides that exceeded expectations, but it was smaller, at just 4.5 percent.
To ensure the decline in suicides did not reflect a general improvement in young-adult mortality, the researchers tracked cancer deaths, and found there was no change. They also looked at the rates of suicide among young people in England, where no change had been made to the national crisis line in that time period; they found no reduction in youth suicides there.
Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, said she was persuaded that the hotline had contributed to the improvement in suicide rates, in part because it did not appear among English youths or in older Americans.
“To me, that really helps hone in that this might really be the differentiator,” she said. “We are seeing potentially a pretty significant decline in suicides among young people. For public policy, this is strong evidence to double down on that we are doing.”
Emily Hilliard, a senior press secretary at the Department of Health and Human Services, said H.H.S. and SAMHSA are “committed to ensuring that all Americans have access” the 988 line, which she said “clearly provides lifesaving support, helping millions of people every year.”
If you are having thoughts of suicide, call or text 988 to reach the 988 Suicide and Crisis Lifeline or go to SpeakingOfSuicide.com/resources for a list of additional resources.
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A highly contagious digestive virus is surging across the U.S., experts warn.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain.
The virus primarily affects infants and young children, but there have also been outbreaks in elderly populations, such as nursing homes.
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Data from the Centers for Disease Control and Prevention shows that in the week ending April 4, out of 2,329 rotavirus tests, 7.3% were positive for the infection. Last year’s highest infection rate was 6.77% as of the week ending April 19.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain. (iStock)
“We’re seeing a lot of rotavirus in the wastewater right now,” Dr. Marc Siegel, Fox News senior medical analyst, confirmed to Fox News Digital. “Testing for rotavirus is way down, but the percentage of positive tests is up.”
While the virus typically peaks in the spring, it is not currently slowing down, he noted.
Why cases may be rising
Patricia Pinto-Garcia, M.D., a medical editor at GoodRx who is based in California, said there are several possible reasons for the rotavirus spike.
“Vaccine rates are down overall among young children, as they decreased during COVID,” she told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.”
The rotavirus vaccine series must be completed by the time a child is 8 months old, she noted.
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As a result of the declining vaccinations, herd immunity isn’t protecting vulnerable children, according to Pinto-Garcia. “Children who haven’t finished the vaccine series yet, are too young to get vaccinated, or can’t get the vaccine due to medical illness are more likely to get exposed to the illness because other children aren’t vaccinated,” she said.
Siegel noted that before the vaccine became available, rotavirus resulted in 55,000 to 70,000 in the U.S. per year.
“Vaccine rates are down overall among young children, as they decreased during COVID,” a doctor told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.” (iStock)
“I am concerned that the vaccination rate has been declining over the past seven years and is continuing to decline in the current climate of vaccine skepticism,” he said.
Surveillance methods are also much better than they used to be, Pinto-Garcia noted, which means public health experts are able to pick up and track cases better than ever before.
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“But we see that rotavirus-related healthcare visits are also up, so improved detection is not the only reason we are seeing this spike,” she said.
The COVID pandemic also disrupted the pattern of infections, according to Pinto-Garcia, so it’s “tricky” to compare the current levels against older cycles.
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor,” she added.
Transmission and risk
Dr. Zachary Hoy, a pediatric infectious disease specialist at Pediatrix Medical Group based in Nashville, Tennessee, often sees young patients with rotavirus.
“Rotavirus is spread via the fecal-oral route, meaning that a person comes into contact with virus droplets from contact with other children or adults, or from contact with objects such as toys that have been contaminated with the virus from someone who is sick,” he told Fox News Digital. “This can lead to outbreaks, especially at schools where many young children share the same toys.”
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor.”
Rotavirus is associated with many dehydration cases in the hospital due to the degree of diarrhea, according to Hoy.
In some severe cases, the virus can lead to seizures due to electrolyte imbalances from dehydration and loss of electrolytes in the stool.
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“Younger children do not have the reserves that older children and adults have, so they can become more dehydrated quicker and develop more severe electrolyte imbalances, leading to more severe infections,” Hoy said.
“Patients with problems with their immune systems or on medications that can decrease their immune systems can have more severe and prolonged infections, too.”
Treatment and care
Because rotavirus is a viral infection, antibiotics are not effective against it. There is no specific antiviral treatment for the condition, with doctors typically recommending supportive care.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” Hoy told Fox News Digital. “Sometimes it can take up to two to three days of IV fluids to help get patients rehydrated.”
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Blood draws are often necessary to evaluate patients’ electrolyte levels, such as sodium, potassium, calcium and magnesium, according to the doctor.
“If these electrolyte levels are significantly low, sometimes patients need special IV solutions or individual electrolyte medications,” he added.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” a doctor told Fox News Digital. (iStock)
Dr. Daniel Park, medical director of the Pediatric Emergency Department at UNC Health in Chapel Hill, North Carolina, noted that most children recover with supportive care, but parents should seek medical attention if a child shows signs of dehydration. Those include decreased urination, lethargy or inability to keep fluids down.
“While rare, rotavirus can be life-threatening in vulnerable populations, especially very young infants or children with underlying medical conditions,” Park told Fox News Digital.
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Prevention strategies
Given the lack of antiviral medications for rotavirus, doctors emphasize the importance of prevention, primarily the vaccine.
There are two rotavirus vaccines – Rotateq (a three-dose series) and Rotarix (a two-dose series). They are given starting at age 2 months as oral drops, not injections, according to Hoy.
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“It’s important to get the rotavirus vaccines on schedule, because these younger infants are at greatest risk if they get rotavirus,” he advised.
Other recommended prevention methods include handwashing with soap and water.
Every day we’re faced with a zillion small choices: Go to sleep early, or watch one more episode of that Netflix drama. Call an old friend to catch up, or cruise social media. Of course, no single action will guarantee a long, healthy life or doom you to an early grave. But those little daily decisions do add up, and over the long term they can make a difference when it comes to both your longevity and your health span, the amount of life spent in relatively good health.
Scroll through this theoretical “day in the life” and select the option that best fits your typical day. Not every situation will apply perfectly, but think about which choice you’d be most likely to make. This isn’t a formal scientific assessment. The goal here isn’t to assign you a “good” or “bad” score, but to help you understand the central factors that shape the way we age and how long we live.
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