FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans https://ift.tt/QJpEbID
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.
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 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."
VETERAN HOMELESSNESS SEES LARGEST SPIKE IN 12 YEARS, VA REPORTS: ‘WE HAVE FAILED,’ LAMENTS ARMY VET
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."
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."
"There were also individual veterans who had undergone the therapy and talked about this life-saving treatment they received," she added.
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."
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."
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
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."
"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.
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."
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.
For more Health articles, visit www.foxnews/health
"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."
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.
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 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."
VETERAN HOMELESSNESS SEES LARGEST SPIKE IN 12 YEARS, VA REPORTS: ‘WE HAVE FAILED,’ LAMENTS ARMY VET
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."
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."
"There were also individual veterans who had undergone the therapy and talked about this life-saving treatment they received," she added.
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."
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."
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
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."
"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."
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
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.
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."
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.
For more Health articles, visit www.foxnews/health
"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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