Trump signs order to speed up drug review

WASHINGTON (AP) — President Donald Trump on Saturday directed his administration to speed up reviews of some psychedelic drugs, including ibogaine, which have recently been embraced by veterans and conservative lawmakers despite serious safety risks.

Ibogaine and other narcotics remain banned under the federal government’s most restrictive category of high-risk illegal drugs. But the administration is taking steps to ease restrictions and stimulate research into the use of the drugs for medical purposes, including conditions such as major depression.

“Today’s order will ensure that people suffering from debilitating symptoms may finally have a chance to reclaim their lives and live happier lives,” Trump said as he signed an executive order on the drugs. The Republican president said his guidance would help “dramatically accelerate” access to potential treatments. “If this turns out to be as good as people say it is, it will have a huge impact,” he said.

Veteran organizations and psychedelic advocates have long claimed that ibogaine, which is made from a shrub native to West Africa, has great promise for hard-to-treat conditions, such as post-traumatic stress disorder and opioid addiction.

Trump’s announcement follows pledges by Health Secretary Robert Kennedy Jr. and other administration officials to make the drug more accessible for medical use, an issue that has received rare bipartisan support.

Trump was joined in the Oval Office by top health officials, conservative broadcaster Joe Rogan, and Marcus Luttrell, the former Marine whose memoir about a deadly mission in Afghanistan was the basis of the movie “Lone Survivor.” Rogan said he texted Trump with information about ibogaine and the president responded: “Sounds great. Do you want FDA approval? Let’s do it.”

“You’re going to save a lot of lives by doing this,” Luttrell told Trump during the ceremony. “You have completely changed my life for the better.”

Next week, the Food and Drug Administration will issue National Priority Vouchers for three psychedelic drugs, which the agency’s commissioner, Marty McCurry, said will allow certain drugs to be approved quickly “if they align with our national priorities.” Vouchers can reduce review times from several months to a period of weeks. This is the first time the FDA has provided such fast tracking for any drug.

The Food and Drug Administration is also taking steps to pave the way for the first-ever human trials of ibogaine in the United States

Trump’s action surprised many advocates and longtime psychedelic researchers, given that ibogaine is known to cause sometimes fatal heart problems. The National Institutes of Health briefly funded research on the drug in the 1990s, but discontinued the work due to ibogaine’s “cardiovascular toxicity.”

“Ibogaine has been very difficult to study in the United States because of its known cardiotoxicity,” said Frederick Barrett, director of the Johns Hopkins Center for Psychedelic and Consciousness Research. “If the executive order can pave the way for objective scientific research with this compound, it will help us understand whether it is truly a better psychedelic treatment than others.”

No drugs have been approved in the United States, but a number are being studied in large trials for various mental health conditions, including psilocybin, ecstasy, and LSD. All of these drugs remain illegal, classified as Schedule I substances along with narcotics such as heroin. Two states – Oregon and Colorado – have legalized psychedelic treatment using psilocybin.

Ibogaine was first used by members of the Bwiti religion in African countries such as Gabon during their religious ceremonies.

In recent years, American veterans have reported benefiting from the drug after traveling to clinics that offer it in Mexico.

Support from veterans groups and former Texas Gov. Rick Perry led to a law last year providing $50 million for ibogaine research in that state. Perry, who co-founded a group called Americans for Ibogaine, recently appeared on Rogan’s radio show, calling for lower federal limits on the drug. This was the second time he spoke about ibogaine on the popular podcast in the past two years.

Trump’s order calls for the Department of Health and Human Services to direct at least $50 million to states that have enacted or are developing programs to develop psychedelics for serious mental illness. It is described as a federal-state partnership to provide funding, technical assistance and data sharing.

Ibogaine is known to cause irregular heartbeats, and has been linked to more than 30 deaths in the medical literature, according to the Interdisciplinary Association for Psychiatric Studies, a nonprofit organization that has conducted some early studies on patients outside the United States.

Trump’s order may encourage other states to follow the Texas model, said Ismail Loredo Ali, the group’s co-executive director.

“The stigma surrounding Schedule I drugs is huge,” Ali said. “It would seem that this would provide too much cover for Republican governors and legislatures to get into the ring in terms of funding research programs at their universities.”

Ibogaine clinic owners said the effect of the order would not be immediate.

“There will be no insurance coverage, and it will still be considered unapproved, uncovered care,” said Tom Vigil of Beond Ibogaine, which runs a clinic in Cancun, Mexico. “But what it means is that ibogaine goes from being fringe and underground to being federally recognized.”

Vigil says his clinic treated 2,000 people with ibogaine last year at a cost of between $15,000 and $20,000 per person. The company also provided free treatment to about 100 veterans.

Clinics that use the drug usually monitor patients’ heart readings and have emergency medical equipment on hand.

One of the only recent studies by US researchers found that veterans treated with ibogaine showed improvement in symptoms of traumatic brain injury, including PTSD, depression and anxiety. The Stanford study was small, including 30 veterans who received the drug in Mexico. It did not include a placebo group for comparison, an essential feature of rigorous medical research. Patients in the study received a combination of ibogaine mixed with magnesium intended to reduce heart risk.