Trump administration fast-tracks ibogaine research for PTSD

Health and Human Services Secretary Robert F. Kennedy Jr. announced a more than $25 million investment from his department, along with the Department of Veterans Affairs, to speed up research on ibogaine as a possible treatment for PTSD, addiction, and other mental health disorders.“On Veterans Day, Americans recognized the service of our military veterans,” Kennedy said. “Our responsibility includes investing in research that could improve their care and giving vets accurate information about potential treatments.” Kennedy said the Advanced Research Projects Agency for Health, or ARPA-H, is committing up to $4.9 million to advance ibogaine research for PTSD to fast-track clinical trial development. The National Institute for Mental Health also announced a $20 million grant funding opportunity for other rapid action psychotropic drugs, including ketamine, esketamine, and psilocybin.The funding announcement comes after President Donald Trump signed an executive order in April directing the Food and Drug Administration and other federal health agencies to expedite their review of certain psychedelics.Ibogaine, a naturally occurring compound from a plant native to Africa, is used in other countries to treat depression, anxiety, addiction, PTSD, and brain trauma.Because ibogaine is a Schedule I controlled substance, the highest level of restriction set by the Drug Enforcement Agency, Americans in recent years have traveled outside of the U.S. to unregulated clinics, often in Mexico or the Caribbean, for treatment.Several Trump administration officials said the goal of the cross-departmental research program was to ensure safety and efficacy research on ibogaine and other possible psychotherapeutic drugs occurs domestically.Andrew Gradison, senior adviser to the Veterans Health Administration, said at a press conference that the integration of HHS regulatory frameworks and VA health systems is “building the infrastructure to answer critical questions for veterans while raising the standards we demand to protect them.”“For veterans living with PTSD, we owe them both urgency and the best science we can produce,” Gradison said, adding that the announcement is “a commitment to generate reliable evidence, be completely transparent about what the science shows, and expand access only if the data support it.”Recent studies from Stanford University relying on treatment outside the United States have shown that small cohorts of veterans have both lower PTSD symptoms and improved executive functioning following treatment with ibogaine.In a Stanford study from October, the veterans’ PTSD symptoms had improved on average by 88% after one month following ibogaine treatment. After 12 months, the likelihood of sustained remission was 84% for PTSD.Kennedy also said HHS and the VA have negotiated with billionaire Mark Cuban’s company Cost Plus Drugs to keep the price of ibogaine treatment low should the drug pass clinical safety and efficacy trials.“We are addressing affordability during development as well,” Kennedy said. “If this work succeeds and the medicine earns FDA approval, our pricing will be comparable to that of other generic drugs thanks to the agreement that we’ve made with Mark Cuban.”Mehmet Oz of the Centers for Medicare and Medicaid Services said during the press conference that his agency would be working to create payment models for veterans and others on federally funded health insurance programs to participate in clinical trials for ibogaine and other drugs before they reach the market.ARLINGTON GUARD SCOLDS HEGSETH’S ENTOURAGE FOR LAUGHING NEAR TOMB OF THE UNKNOWN SOLDIER“We’re building on the kinds of insights that are currently available, not ignoring them with an old-fashioned paradigm that wasn’t working anymore for their well-being,” Oz said. “Nothing speaks to the PTSD crisis we have in America more than that reality.”Veterans Affairs Secretary Doug Collins was scheduled to be at the event at the Hubert Humphrey building in Washington, D.C., but Kennedy said his counterpart was unable to attend due to an active shooter incident in the district.