Health
Study on MDMA’s use to treat PTSD could send therapy method to FDA for approval by 2024
A new study published last week suggests the psychedelic drug MDMA, also known as Ecstasy or Molly, can reduce symptoms of post-traumatic stress disorder, and some expect the treatment to be approved by 2024.
The Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research and educational organization that was formed in 1986 and focuses on the medical, legal and cultural contexts for how people can benefit from the “careful” uses of psychedelics and marijuana, sponsored the study.
“Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPS-sponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024,” MAPS founder and president Rick Doblin said.
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The results for the third phase of the study were published in Nature Medicine on Sept. 13, 2024.
During the study, researchers measured the symptoms and results of 104 people suffering from PTSD, who were randomly assigned to be prescribed MDMA or a placebo pill over the course of three sessions, one month apart. Both groups, the study notes, were given talk therapy during the process.
One person dropped out of the MDMA group during the study, and some of the side effects felt in the MDMA group included nausea, sweating, muscle tightness and a decreased appetite.
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A standard PTSD assessment measuring things like flashbacks, nightmares and insomnia found that 86% of the MDMA group improved, compared to 69% in the placebo group.
Once the study was complete, 72% of those in the MDMA group no longer met the criteria to be diagnosed with PTSD, compared with 48% of the people in the placebo group.
In July, Australia became the first country to allow psychiatrists to prescribe certain psychedelic substances to patients with depression or PTSD.
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The approval of the therapy meant Australian physicians could now prescribe doses of MDMA, while psilocybin, the psychoactive ingredient in psychedelic mushrooms, can now be given to those with hard-to-treat depression.
The U.S. Food and Drug Administration designated psilocybin as a “breakthrough therapy” in 2018, a label that’s designed to speed the development and review of drugs to treat a serious condition. Psychedelics researchers have benefited from federal grants, including Johns Hopkins, and the FDA released draft guidance late last month for researchers designing clinical trials testing psychedelic drugs as potential treatments for a variety of medical conditions.
Still, the American Psychiatric Association has not endorsed the use of psychedelics in treatment.
Medical experts in the U.S. and elsewhere, Australia included, have cautioned that more research is needed on the drugs’ efficacy and the extent of the risks of psychedelics, which can cause hallucinations.
The Associated Press contributed to this report.
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Health
FDA bans red food dye due to potential cancer risk
The U.S. Food and Drug Administration (FDA) has officially banned red dye — called Red 3, or Erythrosine — from foods, dietary supplements and ingested medicines, as reported by the Associated Press on Wednesday.
Food manufacturers must remove the dye from their products by January 2027, while drug manufacturers will have until January 2028 to do so, AP stated.
Any foods imported into the U.S. from other countries will also be subject to the new regulation.
RED FOOD DYE COULD SOON BE BANNED AS FDA REVIEWS PETITION
“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, the FDA’s deputy commissioner for human foods, in a statement.
“Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3,” he continued. “Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”
The synthetic dye, which is made from petroleum, is used as a color additive in food and ingested drugs to give them a “bright cherry-red color,” according to an online statement from the FDA.
The petition to ban the dye cited the Delaney Clause, which states that the agency cannot classify a color additive as safe if it has been found to induce cancer in humans or animals.
The dye was removed from cosmetics nearly 35 years ago due to potential cancer risk.
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“This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy,” said Dr. Peter Lurie, director of the group Center for Science in the Public Interest, which led the petition effort, as reported by AP.
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, applauded the FDA’s ban.
“It was a long time coming,” he told Fox News Digital. “It’s been more than 30 years since it was banned from cosmetics in the U.S. due to evidence that it is carcinogenic in high doses in lab rats. There needs to be a consistency between what we put on our skin and what we put into our mouths.”
“There needs to be a consistency between what we put on our skin and what we put into our mouths.”
Siegel said he believes the FDA’s decision could be tied to the incoming new head of the Department of Health and Human Services, Robert F. Kennedy Jr.
“They knew it would have happened anyway under RFK Jr.,” he said. “It is already banned or severely restricted in Australia, Japan and the European Union.”
The food additive also “drew kids in” to a diet of empty calories and ultraprocessed foods, Siegel added.
“It has also been linked to behavioral issues in children, including ADHD.”
Nearly 3,000 foods are shown to contain Red No. 3, according to Food Scores, a database of foods compiled by the Environmental Working Group.
For more Health articles, visit www.foxnews.com/health
The National Confectioners Association provided the below statement to Fox News Digital.
“Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards.”
The petition to remove Red No. 3 from foods, supplements and medications was presented in 2022 by the Center for Science in the Public Interest and 23 other organizations and scientists.
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