Health
FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans
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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.”
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A new report by the American Heart Association (AHA) included some troubling predictions for the future of women’s health.
The forecast, published in the journal Circulation on Wednesday, projected increases in various comorbidities in American females by 2050.
More than 59% of women were predicted to have high blood pressure, up from less than 49% currently.
The review also projected that more than 25% of women will have diabetes, compared to about 15% today, and more than 61% will have obesity, compared to 44% currently.
As a result of these risk factors, the prevalence of cardiovascular disease and stroke is expected to rise to 14.4% from 10.7%.
The prevalence of cardiovascular disease and stroke in women is expected to rise to 14.4% from 10.7% by 2050. (iStock)
Not all trends were negative, as unhealthy cholesterol prevalence is expected to drop to about 22% from more than 42% today, the report stated.
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Dr. Elizabeth Klodas, a cardiologist and founder of Step One Foods in Minnesota, commented on these “jarring findings.”
“The fact that on our current trajectory, cardiometabolic disease is projected to explode in women within one generation should be a huge wake-up call,” she told Fox News Digital.
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“Hypertension, diabetes, obesity — these are all major risk factors for heart disease, and we are already seeing what those risks are driving. Heart disease is the No. 1 killer of women, eclipsing all other causes of death, including breast cancer.”
Cardiovascular disease is the leading cause of death for women in the U.S. and around the world. (iStock)
Klodas warned that heart disease starts early, progresses “stealthily,” and can present “out of the blue in devastating ways.”
The AHA published another study on Thursday revealing one million hospitalizations, showing that heart attack deaths are climbing among adults below the age of 55.
The more alarming finding, according to Klodas, is that young women were found more likely to die after their first heart attack than men of the same age.
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“This is all especially tragic since heart disease is almost entirely preventable,” she said. “The earlier you start, the better.”
Children can show early evidence of plaque deposition in their arteries, which can be reversed through lifestyle changes if “undertaken early enough and aggressively enough,” according to the expert.
Moving more is one part of protecting a healthy heart, according to experts. (iStock)
Klodas suggested that rising heart conditions are associated with traditional risk factors, like smoking, high blood pressure, high cholesterol, diabetes, obesity and a sedentary lifestyle.
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Doctors are also seeing higher rates of preeclampsia, or high blood pressure during pregnancy, as well as gestational diabetes. Klodas noted that these are sex-specific risk factors that don’t typically contribute to complications until after menopause.
The best way to protect a healthy heart is to “do the basics,” Klodas recommended, including the following lifestyle habits.
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Klodas especially emphasized making improvements to diet, as the food people eat affects “every single risk factor that the AHA’s report highlights.”
“High blood pressure, high blood sugar, high cholesterol, excess weight – these are all conditions that are driven in part or in whole by food,” she said. “We eat multiple times every single day, which means what we eat has profound cumulative effects over time.”
“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health,” a doctor said. (iStock)
“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health.”
The doctor also recommends changing out a few snacks per day for healthier choices, which has been proven to “yield medication-level cholesterol reductions” in a month.
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“Keep up that small change and, over the course of a year, you could also lose 20 pounds and reduce your sodium intake enough to avoid blood pressure-lowering medications,” Klodas added.
“Women should not view the AHA report as inevitable. We have power over our health destinies. We just need to use it.”
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Nearsightedness (myopia) is skyrocketing globally, with nearly half of the world’s population expected to be myopic by 2050, according to the World Health Organization.
Heavy use of smartphones and other devices is associated with an 80% higher risk of myopia when combined with excessive computer use, but a new study suggests that dim indoor lighting could also be a factor.
For years, scientists have been puzzled by the different ways myopia is triggered. In lab settings, it can be induced by blurring vision or using different lenses. Conversely, it can be slowed by something as simple as spending time outdoors, research suggests.
Nearsightedness occurs when the eyeball grows too long from front to back, according to the American Optometric Association (AOA). This physical elongation causes light to focus in front of the retina rather than directly on it, making distant objects appear blurry.
The study suggests that myopia isn’t caused by the digital devices themselves, but by the low-light environments where they are typically used. (iStock)
Researchers at the State University of New York (SUNY) College of Optometry identified a potential specific trigger for this growth. When someone looks at a phone or a book up close, the pupil naturally constricts.
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“In bright outdoor light, the pupil constricts to protect the eye while still allowing ample light to reach the retina,” Urusha Maharjan, a SUNY Optometry doctoral student who conducted the study, said in a press release.
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“When people focus on close objects indoors, such as phones, tablets or books, the pupil can also constrict — not because of brightness, but to sharpen the image,” she went on. “In dim lighting, this combination may significantly reduce retinal illumination.”
High-intensity natural light prevents myopia because it provides enough retinal stimulation to override the “stop growing” signal, even when pupils are constricted. (iStock)
The hypothesis suggests that when the retina is deprived of light during extended close-up work, it sends a signal for the eye to grow.
In a dim environment, the narrowed pupil allows so little light through that the retinal activity isn’t strong enough to signal the eye to stop growing, the researchers found.
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In contrast, being outdoors provides light levels much brighter than indoors. This ensures that even when the pupil narrows to focus on a nearby object, the retina still receives a strong signal, maintaining healthy eye development.
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The team noted some limitations of the study, including the small subject group and the inability to directly measure internal lens changes, as the bright backgrounds used to mimic the outdoors made pupils too small for standard equipment.
Researchers believe that increasing indoor brightness during close-up work could be a simple, testable way to slow the global nearsightedness epidemic. (iStock)
“This is not a final answer,” Jose-Manuel Alonso, MD, PhD, SUNY distinguished professor and senior author of the study, said in the release.
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“But the study offers a testable hypothesis that reframes how visual habits, lighting and eye focusing interact.”
The study was published in the journal Cell Reports.
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