vlog

Skip to content
NOWCAST vlog News at 6am Weekday Mornings
Watch on Demand
Advertisement

With FDA decision looming, bipartisan group of lawmakers urge support for MDMA to treat PTSD

With FDA decision looming, bipartisan group of lawmakers urge support for MDMA to treat PTSD
FUNNY AND WHAT’S NOT IN AN ELECTION YEAR. WE START WITH THE PUSH TO LEGALIZE PSYCHEDELICS FOR MENTAL HEALTH CARE. IT’S A MOVEMENT GAINING STEAM, THANKS IN PART TO THE VOICES OF AMERICA’S VETERANS. RESEARCHERS ARE LOOKING AT DRUGS LIKE PSILOCYBIN, THE PSYCHOACTIVE INGREDIENT IN MAGIC MUSHROOMS AND MDMA, KNOWN AS THE CLUB DRUG ECSTASY. BOTH ARE SHOWING PROMISE FOR TREATING MENTAL HEALTH DISORDERS LIKE DEPRESSION AND PTSD. WHEN PAIRED WITH TALK THERAPY, DOZENS OF CLINICAL TRIALS ARE NOW UNDERWAY, LOOKING AT WHETHER THESE THERAPIES CAN HELP WITH OTHER ISSUES LIKE OCD, EATING DISORDERS, EVEN ALCOHOL AND OPIOID ADDICTION. OUR CORRESPONDENT JESSICA GOMEZ TRAVELED TO BOTH COASTS TO LEARN MORE. READY? MIXED MARTIAL ARTS. PART OF NIGEL MCCURRY’S MENTAL HEALTH CARE ROUTINE. OH, GNARLY. VERY NICE. IT’S BEEN A REALLY EXCELLENT WAY FOR ME TO BE ABLE TO RELEASE ANXIETY AND NERVOUS ENERGY. NIGEL WAS 21 WHEN HE JOINED THE MARINES IN 2003, AND WITHIN A YEAR WAS ON THE FRONT LINES OF THE WAR IN IRAQ EVERY DAY WE WERE GETTING SHOT AT GETTING INTO FIREFIGHTS AND THEN WHILE MANNING A TRAFFIC CHECKPOINT, A TERRIBLE ACCIDENT, A TRUCK APPEARING TO IGNORE SIGNALS TO STOP IT JUST KEPT COMING RIGHT AT US, RIGHT AT US. AND SO I STARTED TAKING SHOTS AT IT INSIDE A FAMILY, TWO LITTLE GIRLS KILLED BY THE GUNFIRE. IT WAS GIRLS. THEY DIDN’T THEY DIDN’T DESERVE THAT. WHAT HAPPENED? HAUNTED NIGEL FOR YEARS. BUT I TAKE YOUR MEDICINE. YES. OKAY. UNTIL NOW, HE ENROLLED IN THIS CLINICAL TRIAL STUDYING THE EFFECTS OF MDMA ASSISTED THERAPY ON PATIENTS WITH PTSD. MDMA KNOWN AS THE PARTY DRUG ECSTASY. THE TRIAL, INCLUDING TALK THERAPY. BEFORE, DURING AND AFTER THE DRUG SESSIONS. IT JUST FELT LIKE A LOT OF EMOTIONS THAT I’D BEEN HOLDING DOWN, NOT ALLOWING MYSELF TO FEEL OR JUST COMING UP TO THE SURFACE. TWO THIRDS OF THEM ADD TWO MONTH FOLLOW UP HAD LOST THEIR PTSD DIAGNOSIS, SAYS DR. CHRISTOPHER STAUFFER IS AN ASSOCIATE PROFESSOR OF PSYCHIATRY AT OREGON HEALTH AND SCIENCE UNIVERSITY, AN ADD IN MDMA TRIAL RESEARCHER IF YOU LOOK AT THE NEUROSCIENCE, IT SUPPORTS THIS IDEA THAT WE’RE INCREASING WAIITNG THE WINDOW OF TOLERANCE FOR SOMEONE TO GO INTO THEIR TRAUMA AND DO PSYCHOTHERAPY WORK THAT OTHERWISE WOULDN’T BE TOLERABLE ALL WITHOUT THE MDMA. AND AT JOHNS HOPKINS UNIVERSITY, RESEARCHERS ARE TRYING TO UNDERSTAND HOW PSILOCYBIN THE PSYCHEDELIC COMPOUND IN MAGIC MUSHROOMS CHANGES THE BRAIN WHEN PAIRED WITH PSYCHOTHERAPY. CLINICAL TRIALS SHOWING THE COMBINATION IS EFFECTIVE IN RELIEVING DEPRESSION SYMPTOMS FOR UP TO A YEAR. WE’RE FINDING EARLY EVIDENCE THAT PSYCHEDELICS MAY INCREASE A PERSON’S CAPACITY FOR COGNITIVE FLEXIBILITY. COGNITIVE FLEXIBILITY IS YOUR ABILITY TO THINK DIFFERENTLY ABOUT YOURSELF OR YOUR PLACE IN THE WORLD. YET RESEARCHERS CAUTION THEY’RE STILL MUCH MORE TO LEARN. I THINK THERE’S AN AWFUL LOT TO BE HOPEFUL FOR HERE, BUT WE’RE STILL VERY EARLY IN THE PROCESS AND WE HAVE NOT GATHERED ALL THE DATA THAT WE NEED TO KNOW SO THAT THIS IS TRULY SAFE AND HELPFUL FOR PEOPLE. THIS IS A FLAG THAT I FLEW OVER AFGHANISTAN, BUT VETERANS LIKE GIULIANA MERCER SAY THEY CAN’T AFFORD TO WAIT. THE FORMER MARINE WHO SAYS SHE HAD HER OWN PSYCHEDELIC BREAKTHROUGH. MY LIFE HAS CHANGED COMPLETELY NOW. COACHES, VETERANS SEEKING TREATMENT IN OTHER COUNTRIES WHERE MANY PSYCHEDELICS ARE LEGAL. HAVING SOMETHING THAT’S BEEN BEING USED FOR MILLENNIA BY OTHER CULTURES SAFELY TO HEAL FROM ALL DIFFERENT TYPES OF AILMENTS, TO INCLUDE MENTAL HEALTH IS A RISK THAT WE’RE WILLING TO TAKE. IT JUST RESET EVERYTHING. IT WAS LIKE A HARD DRIVE REBOOT IN SOUTHERN CALIFORNIA THAT REBOOT DRAMATICALLY IMPROVING LIFE FOR MARCUS AND AMBER CAPONES, THE RETIRED NAVY SEAL AMONG THOSE WHO TRAVELED TO MEXICO FOR PSYCHEDELIC HELP, 13 YEARS OF ACTIVE DUTY AND MULTIPLE DEPLOYMENTS HAD TAKEN A TOLL ON HIS MENTAL HEALTH. I WAS MORE AFRAID OF LOSING HIM HERE IN THE UNITED STATES TO HIS OWN HAND THAN I EVER WAS BY AN ENEMY OVERSEAS. WE HAVE TO THINK OUTSIDE THE BOX. WE HAVE TO DO SOMETHING NEW. THE CAPONES AMONG THOSE NOW ADVOCATING FOR FEDERAL FUNDING FOR PSYCHEDELIC RESEARCH AND THEIR NONPROFIT SENDING NEARLY 1000 VETERANS OUT OF THE US FOR HELP. THESE ARE GETTING TO ROOT, ROOT CAUSE ISSUES THAT INDIVIDUALS ARE DEALING WITH AND BEING ABLE TO LIVE THEIR LIFE AGAIN. AND BETTER. YOU CAN DO IT LIVING LIFE AGAIN. FOR NIGEL MCCOURY, IT’S MADE ALL THE DIFFERENCE. WHILE NOT A DAY GOES BY THAT HE DOESN’T THINK ABOUT IRAQ, I WAS ABLE TO REALLY HAVE COMPASSION FOR WHO I WAS WHEN I WAS IN THAT EXPERIENCE AND FORGI
CNN logo
Updated: 3:28 PM CDT Aug 5, 2024
Editorial Standards
Advertisement
With FDA decision looming, bipartisan group of lawmakers urge support for MDMA to treat PTSD
CNN logo
Updated: 3:28 PM CDT Aug 5, 2024
Editorial Standards
In a show of bipartisanship, 80 members of Congress from both sides of the aisle have united in letters urging President Joe Biden and the U.S. Food and Drug Administration to further consider studies on MDMA-assisted therapy for post-traumatic stress disorder — an effort that aims to expedite access to a treatment they hope could help veterans.The coordinated effort is a call for action from the highest levels of government to provide relief to millions of people experiencing PTSD amid a dramatic rise in veteran suicides.“Our country has a severe veteran suicide and PTSD crisis where 6,000 veterans die by suicide each year, with over 150,000 suicides since 9/11,” the Senate letter to FDA Commissioner Dr. Robert M. Califf states. “As a nation, we cannot allow our veterans to continue to suffer in silence and must identify treatments proven to drastically decrease the adverse effects of PTSD. … The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence.”About 5% of adults in the United States — some 13 million people — experience PTSD in any given year, according to estimates from the National Center for PTSD. But current treatment options — including antidepressants and some specialized forms of cognitive behavioral therapy — are limited in their scope and effectiveness, with few alternatives available to help those who don’t respond well to them.One letter is signed by 61 House members and led by Michigan GOP Rep. Jack Bergman, a retired three-star USMC general and the highest-ranking combat veteran in Congress. It is addressed to Biden and copies the secretaries of the Department of Health and Human Services and the Department of Veterans Affairs.Nineteen senators, led by Colorado Democrat Michael Bennet and North Carolina Republican Thom Tillis, addressed their letter to Califf.The House letter says there has been an “astounding lack of innovation the last nearly 25 years has contributed to rising veteran suicide rates. If the data and evidence show it’s safe and effective, we owe it to veterans to make this treatment option available.”“We write today to express our sense of urgency to address the post-traumatic stress disorder (PTSD) and suicide epidemic among Veterans and servicemembers, and the grave need for new and better treatment options like MDMA-assisted therapy,” the letter to Biden reads.The letters were sent as the FDA prepares to issue by Aug. 11 a decision on MDMA, commonly known as ecstasy, to treat PTSD. The treatment is controversial and faces significant hurdles to approval: At a meeting in June, an independent group of advisers to the FDA raised questions about the integrity of the trial studying the treatment and missing safety data. Although “participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms,” the FDA wrote ahead of the meeting, trial data were “challenging to interpret,” including because of bias in efficacy data. Only two of 11 experts advising the FDA said that they considered the treatment effective and only one committee member said that the benefits of the treatment outweigh the risks as presented. Although it’s rare for the FDA to go against its advisers’ recommendation, the agency has the final say.However, the FDA and its advisers acknowledged there’s a significant need for new and better options. No new therapies for PTSD have been approved in more than 20 years — a key point in the new letters.Bipartisan support for MDMA-assisted therapy is gaining momentum after years of pushing from the veteran community, which sees hope in experimental therapies, including the MDMA-assisted therapy from Lykos Therapeutics that’s currently before the FDA.The therapy is the first such treatment to reach this point in the regulatory process. MDMA is known as an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness and emotional openness. It’s currently classified as a Schedule I drug under the Controlled Substances Act, and changing this status would be a marked shift.“It is not our intent to urge the FDA in any direction related to its decision, which must be based solely on the data and evidence. However, we are aware that as this application has made its way through the regulatory review process, certain groups and individuals have voiced criticism of the application. It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA,” the House letter says.VA Under Secretary for Health Dr. Shereef Elnahal has said that current PTSD treatments would “pale in comparison” to preliminary results from MDMA-assisted therapy if they’re able to be replicated, and psilocybin for treatment-resistant depression.“The data and results, the stories that I have heard from veterans who have gone through these studies, these therapies speak for themselves,” Elnahal has said.The VA has taken significant steps over the past months to prepare for the therapy’s potential rollout. This includes issuing a request for applications to assess MDMA-AT’s effectiveness for veterans and forming an integrated project team to handle the anticipated high demand from the veteran community. However, the VA’s ability to administer MDMA-AT hinges on FDA approval.“If the data and evidence show that MDMA-AT is safe and effective at relieving the suffering that many Veterans face, then we owe it to them and the millions of others who are living with PTSD to make this treatment option available to them,” the House letter reads.Another letter, co-authored by 14 veteran service organizations and 730 veterans, was published Monday in conjunction with the congressional letters. “We are confident that if MDMA-AT can be made sufficiently accessible, it will prove to be amongst the most invaluable treatments ever developed to combat the veteran suicide epidemic,” the veteran letter reads in part.

In a show of bipartisanship, 80 members of Congress from both sides of the aisle have united in letters urging President Joe Biden and the U.S. Food and Drug Administration to further consider studies on MDMA-assisted therapy for post-traumatic stress disorder — an effort that aims to expedite access to a treatment they hope could help veterans.

The coordinated effort is a call for action from the highest levels of government to provide relief to millions of people experiencing PTSD amid a dramatic rise in veteran suicides.

Advertisement

“Our country has a severe veteran suicide and PTSD crisis where 6,000 veterans die by suicide each year, with over 150,000 suicides since 9/11,” the Senate letter to FDA Commissioner Dr. Robert M. Califf states. “As a nation, we cannot allow our veterans to continue to suffer in silence and must identify treatments proven to drastically decrease the adverse effects of PTSD. … The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence.”

About 5% of adults in the United States — some 13 million people — experience PTSD in any given year, according to from the National Center for PTSD. But current treatment options — including antidepressants and some specialized forms of cognitive behavioral therapy — are limited in their scope and effectiveness, with few alternatives available to help those who don’t respond well to them.

One letter is signed by 61 House members and led by Michigan GOP Rep. Jack Bergman, a retired three-star USMC general and the highest-ranking combat veteran in Congress. It is addressed to Biden and copies the secretaries of the Department of Health and Human Services and the Department of Veterans Affairs.

Nineteen senators, led by Colorado Democrat Michael Bennet and North Carolina Republican Thom Tillis, addressed their letter to Califf.

The House letter says there has been an “astounding lack of innovation the last nearly 25 years has contributed to rising veteran suicide rates. If the data and evidence show it’s safe and effective, we owe it to veterans to make this treatment option available.”

“We write today to express our sense of urgency to address the post-traumatic stress disorder (PTSD) and suicide epidemic among Veterans and servicemembers, and the grave need for new and better treatment options like MDMA-assisted therapy,” the letter to Biden reads.

The letters were sent as the FDA prepares to issue by Aug. 11 a decision on MDMA, commonly known as ecstasy, to treat PTSD. The treatment is controversial and faces significant hurdles to approval: At a meeting in June, an independent group of advisers to the FDA raised questions about the integrity of the trial studying the treatment and missing safety data. Although “participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms,” the FDA wrote ahead of the meeting, trial data were “challenging to interpret,” including because of bias in efficacy data. Only two of 11 experts advising the FDA said that they considered the treatment effective and only one committee member said that the benefits of the treatment outweigh the risks as presented. Although it’s rare for the FDA to go against its advisers’ recommendation, the agency has the final say.

However, the FDA and its advisers acknowledged there’s a significant need for new and better options. No new therapies for PTSD have been approved in more than 20 years — a key point in the new letters.

Bipartisan support for MDMA-assisted therapy is gaining momentum after years of pushing from the veteran community, which sees hope in experimental therapies, including the MDMA-assisted therapy from Lykos Therapeutics that’s currently before the FDA.

The therapy is the first such treatment to reach this point in the regulatory process. MDMA is known as an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness and emotional openness. It’s currently classified as a Schedule I drug under the Controlled Substances Act, and changing this status would be a marked shift.

“It is not our intent to urge the FDA in any direction related to its decision, which must be based solely on the data and evidence. However, we are aware that as this application has made its way through the regulatory review process, certain groups and individuals have voiced criticism of the application. It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA,” the House letter says.

VA Under Secretary for Health Dr. Shereef Elnahal has said that current PTSD treatments would “pale in comparison” to preliminary results from MDMA-assisted therapy if they’re able to be replicated, and psilocybin for treatment-resistant depression.

“The data and results, the stories that I have heard from veterans who have gone through these studies, these therapies speak for themselves,”

The VA has taken significant steps over the past months to prepare for the therapy’s potential rollout. This includes issuing a request for applications to assess MDMA-AT’s effectiveness for veterans and forming an integrated project team to handle the anticipated high demand from the veteran community. However, the VA’s ability to administer MDMA-AT hinges on FDA approval.

“If the data and evidence show that MDMA-AT is safe and effective at relieving the suffering that many Veterans face, then we owe it to them and the millions of others who are living with PTSD to make this treatment option available to them,” the House letter reads.

Another letter, co-authored by 14 veteran service organizations and 730 veterans, was published Monday in conjunction with the congressional letters. “We are confident that if MDMA-AT can be made sufficiently accessible, it will prove to be amongst the most invaluable treatments ever developed to combat the veteran suicide epidemic,” the veteran letter reads in part.