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. 

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. 

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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.”

As dengue fever continues to spread throughout Europe, experts are blaming an invasive mosquito species as the culprit.

Known as “tiger mosquitoes,” the insects — of the species name Aedes albopictus — have spread into 13 EU countries, according to an alert from the European Centre for Disease Prevention and Control (ECDC).

Elitza Theel, PhD, director of Mayo Clinic Laboratories in Minnesota, confirmed that tiger mosquitoes are a “known vector” for dengue virus and can transmit the virus to individuals who have not previously been infected.

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“This mosquito species is concerning for a number of reasons, including that it is considered the most invasive species in the world,” she told Fox News Digital.

“Although typically considered a tropical mosquito, it is able to survive in cooler climates.”

The mosquito species is moving further and further north globally as temperatures grow warmer, the expert said. 

“Tiger mosquitoes are also rather aggressive, biting both humans and animals at any time of the day, rather than just at dawn or dusk, which is typical of other mosquito species,” Theel warned.

Health officials claimed that climate change is one of the factors contributing to the spread of these insects.

UNDERSTANDING THE SEVERITY OF THE MOSQUITO-BORNE DISEASE DENGUE

“Europe is already seeing how climate change is creating more favorable conditions for invasive mosquitoes to spread into previously unaffected areas and infect more people with diseases such as dengue,” said Andrea Ammon, ECDC director, in a press release from the agency.

“Increased international travel from dengue-endemic countries will also increase the risk of imported cases, and inevitably also the risk of local outbreaks,” she continued. 

“This mosquito species is concerning for a number of reasons.”

“Personal protective measures combined with vector control measures, early detection of cases, timely surveillance, further research and awareness-raising activities are paramount in those areas in Europe most at risk.”

What is dengue fever?

Dengue fever is a virus spread through bites from an infected mosquito. 

It is common in the Americas, Africa, the Middle East, Asia and the Pacific Islands, among other countries, according to the U.S. Centers for Disease Control and Prevention (CDC).

Each year, up to 400 million people are infected, the CDC said.

There is a vaccine available for U.S. children between 9 and 16 years of age who have previously tested positive for dengue and are living in areas where the infection is common.  (iStock)

Typical symptoms include aches and pains (in the eyes, muscles, joints or bones), nausea, vomiting and rash, usually experienced within two weeks of being bitten.

Most people experience symptoms for two to seven days before recovering.

“It’s typically a more mild illness, but can be severe, causing headaches, joint pain, fever, abdominal pain and even death,” Dr. Mark Fischer, regional medical director of International SOS, a leading medical and security services company, told Fox News Digital. 

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“One of the reasons for the higher rate of infection is due to the fact that the tiger mosquito, the carrier of dengue, has adapted to living in urban environments and alongside humans,” said Pennsylvania-based Fischer.

There is not currently a medication to treat dengue, the CDC noted. 

“This species … has established populations in several [U.S.] states.”

Infected people are advised to rest, take acetaminophen for pain and fever, stay hydrated and see a doctor.

There is a vaccine available for U.S. children between 9 and 16 years of age who have previously tested positive for dengue and are living in areas where the infection is common. 

Dengue fever in the US

While dengue fever is most prevalent in the tropics and subtropics, experts warn that it’s also rising globally.

“Based on information from the National Invasive Species Information Center, this species of mosquito was first identified in the United States in 1985 and has established populations in several states,” Fischer told Fox News Digital.

Typical symptoms include aches and pains (in the eyes, muscles, joints or bones), nausea, vomiting and rash, usually experienced within two weeks of being bitten by an infected mosquito. (iStock)

There does not currently seem to be an immediate threat of tiger mosquitoes to the U.S., however, noted Fischer.

“That said, with climate change affecting the globe and tiger mosquitoes thriving in warm temperatures and in urban cities, it is possible that they can become an increasing danger in the coming months and years,” he said.

In 2024, there were 1,984 dengue cases in the U.S., according to CDC data.

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Most of those were reported by people who had been infected outside the country before returning.

“Although this species of mosquito is currently found in the U.S., at present it is considered a nuisance mosquito, because the viruses it is competent to transmit are not circulating or endemic in the United States,” Theel said.

Other risks of mosquitoes

Mosquitoes are considered the world’s deadliest animal because they transmit so many dangerous pathogens, with dengue being the most common — “over 390 million infections annually worldwide,” Theel noted.

While dengue is one of the “most concerning viral pathogens” that mosquitoes transmit, Theel warned that they also transmit malaria, which causes over 240 million infections each year and remains a serious problem in Africa and regions of southeast Asia. 

Mosquitoes are considered the world’s deadliest animal because they transmit so many dangerous pathogens. Dengue is the most common — “over 390 million infections annually worldwide,” one expert noted. (iStock)

“These mosquitoes can also transmit other viruses, like Chikungunya virus and Zika virus, to humans — and dirofilaria, a parasitic nematode, to both dogs and humans,” she said.

“The West Nile Virus, St. Louis Encephalitis virus and Eastern Equine Encephalitis virus are some of the mosquito-borne viruses that we are concerned with annually in the U.S., all of which can lead to severe neurologic disease and sequelae,” Theel added.

“Each year, one million people die from mosquito-related illness, so these insects do pose a serious threat to global health.”

Depending on where in the world they reside, some people may be more at risk for some of these illnesses than others, said Fischer. 

“It is important to check your local government resources to see which, if any, of these diseases you may be most susceptible to and make sure you are taking proper precautions to avoid mosquito-borne illness,” he advised.

“Each year, one million people die from mosquito-related illness, so these insects do pose a serious threat to global health.”

Prevention of mosquito-borne disease

In its alert, the ECDC called for “efficient but eco-friendly tools to manage mosquito populations” and recommended “removing stagnant water in gardens or balconies where mosquitoes breed.”

“It’s important to wear insect repellent that contains DEET, picaridin or lemon and eucalyptus oil, as these ingredients are the most effective at repelling mosquitoes and other insects,” Fischer advised. 

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“Those who live in areas with mosquito populations should try to wear long-sleeved shirts and long pants, especially at dusk and in the evening, when mosquitoes are most active, to avoid getting bitten on exposed skin.”

Keeping screens on windows and doors is also a good way to prevent insects from entering and potentially causing the spread of disease, he said. 

Individuals should always use EPA-registered insect repellent when outdoors in areas where mosquitoes and ticks are prevalent, an expert advised. (iStock)

“If you live in an area that has a high level of mosquito-borne diseases, you should use mosquito nets when sleeping and eliminate any standing water in and around the home, since still bodies of water are breeding grounds for the insects,” Fischer recommended.

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“Individuals should always use EPA-registered insect repellent when outdoors in areas where mosquitoes and ticks are prevalent — particularly at dawn and dusk when mosquitoes are most active,” Theel recommended. 

For more Health articles, visit www.foxnews/health

“If camping or spending prolonged time outdoors and in forested areas, individuals could consider treating their clothing with permethrin to repel insects as well.”

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Health officials in Virginia are investigating a surge of brutal gastrointestinal illnesses reported in children who were at a popular lake over Memorial Day weekend, with a number of them ending up in a hospital.

The Virginia Department of Health (VDH) says that some people who were in the water at Lake Anna have been diagnosed with Escherichia coli (E. coli) infections, which cause stomach cramps and diarrhea. Symptoms can also include vomiting, fever, chills and, in severe cases, the infection can damage organs such as the kidneys. 

Most kinds of E. coli are harmless, but some can make someone sick, the Centers for Diseases and Infections said.

Judy Inglett, a mother from Fauquier County, said her 15-year-old daughter came down with symptoms after she returned from Lake Anna, and she has had at least two rounds of dialysis since being hospitalized.

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“It’s a parent’s worst nightmare,” Inglett told Fox 10 News. “She left on that Friday, on that weekend, and she was fine. And now she is, like, fighting for her life.”

Inglett said her daughter has been diagnosed with hemolytic uremic syndrome, a rare but serious disease that affects the kidneys and blood clotting functions of infected people.

“She’s in kidney failure. I wouldn’t even let my dogs swim in that lake. There is definitely something going on. It’s not safe,” Inglett told the outlet.

The VDH said in a press release last week that clinical evaluation and treatment of patients is ongoing. 

The agency said that it is investigating all potential causes of illness, including lake water and food exposures. Lake Anna is one of the largest freshwater inland reservoirs in Virginia, covering an area of 13,000 acres and is located 72 miles south of Washington, D.C. 

E. COLI STRAIN LINKED TO LEAFY GREENS ASSOCIATED WITH OUTBREAKS, RESEARCH LED BY CDC DOCTOR SAYS

Swimming, fishing and boating are allowed on the lake. (Ben Hasty/MediaNews Group/Reading Eagle via Getty Images)

“While all the ill people confirm swimming or other water exposures in Lake Anna, VDH does not have enough information at this time to confirm that exposure to the lake, or any specific portion of the lake is the cause of the illnesses,” the VDH press release read. “Water testing of the lake to evaluate present concentrations of bacteria, and to determine whether a public health risk may be ongoing, is being conducted.”

The illnesses are not suspected as Harmful Algal Bloom (HAB) related, as the pathogen is not associated with HABs, the VDH said. Fox News Digital has reached out to the department for updates.

“There is definitely something going on. It’s not safe.”

— Judy Inglett

Another parent, Nate Hiner, told Fox 10 News that his 8-year-old twins were sent to Children’s National Hospital. His daughter received blood and platelet transfusions.

Hiner also said he believes the symptoms stem from their Memorial Day weekend lake visit.

“It’s terrifying to just go from having a fun day at the lake to potentially needing dialysis in an 8-year-old child. It’s just unfathomable to think of as a parent,” he told the outlet. 

Swimming, fishing and boating are allowed on the reservoir that spans Louisa, Spotsylvania and Orange counties, according to Virginia State Parks.

Some neighbors told Fox 10 News that they were not surprised to learn the lake might be contaminated since large groups of people dock their boats at a sandbar, with some using the water when they need to use the bathroom.

The VDH said it did not have enough information to support a swimming advisory but does encourage caution when swimming.

E. coli bacteria of the O157:H7 strain seen under a microscope. (Janice Haney Carr/CDC via AP, File)

“As we head to pools, lakes, and beaches to enjoy the warmer weather and spend time with our families, it is important to remember to take precautions to prevent illness,” Dr. Olugbenga O. Obasanjo, the Rappahannock health district health director, said.

“Showering before and after swimming, washing your hands before eating, and being sure not to drink the lake water are some of the ways to stay healthy this summer.”

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“It is also important not to swim if you have diarrhea. Children may need extra monitoring and reminders to follow these precautions. Germs in water can cause minor illnesses (rashes, diarrhea) or more serious illnesses that last longer than vacation.”