“We intend to fully fund this program.”
Texas is launching its own research program into a psychedelic called ibogaine after state officials couldn’t find a company to help develop it into a drug for Food and Drug Administration (FDA) approval.
Lt. Gov. Dan Patrick (R) and House Speaker Dustin Burrows (R) announced on Tuesday that Texas will use $50 million the Legislature invested last year and partner with statewide medical researchers to proceed with its own ibogaine research program. The lawmakers said multiple proposals from drug companies failed to meet the standards for state funds.
“We intend to fully fund this program,” the statement says.
Katharine Neill Harris, a drug policy fellow at Rice University’s Baker Institute for Public Policy, said she isn’t surprised the state couldn’t woo any companies to join in on ibogaine research.
Texas lawmakers set the bar too high that to even be eligible for the $50 million state investment, companies had to provide a plan to get FDA approval to develop ibogaine into a drug, create a corporate presence in Texas, match the $50 million and commit to Texas 20 percent of revenue from future sales of the drug after the FDA approves it, Harris said.
“That may be seen as a demanding state of conditions in a research area that carries substantial risk, so it is believable that prospective applicants did not meet the requirements,” Harris said.
For several years, people have silently traveled to clinics in Mexico to take ibogaine. The extract of an ancient African shrub, ibogaine has been used to alleviate addiction and brain trauma. Ibogaine is an illegal drug, but Republicans have championed it due to its positive impact on people suffering from PTSD.
Gov. Greg Abbott (R) signed Senate Bill 2308 into law last year, creating a consortium of universities, hospitals, and drug developers to conduct clinical trials of an ibogaine drug and get it approved by the FDA for future sale. Lawmakers approved $50 million in taxpayer dollars to support this effort, making Texas a leader in psychedelic research investment.
Getting drug companies on board was key to making this consortium work because they have the experience of developing a drug that gets FDA approval.
The Texas Tribune asked Patrick, Burrows and the Texas Health and Human Services commission why companies didn’t qualify to partner with the state and what next steps will involve. They did not provide answers by the story’s deadline.
Bryan Hubbard, chief executive officer of Americans for Ibogaine, said research institutions across the country are conducting hundreds of clinical trials everyday, but what sets Texas apart is its goal of developing ibogaine into an FDA-approved drug that can be sold.
“As we speak we are seeing bills passed in Mississippi, West Virginia, Oklahoma, Tennessee and Missouri that would join these states together in researching ibogaine, something far more significant than one private developer,” he said. “Texas is what makes this joiner possible.”
Under SB 2308, a public university will manage ibogaine clinical trials in partnership with a drug company and a hospital.
Harris said if the state plans to move forward without a drug company, the state might need to make some legislative or legal fixes to meet the statutory requirements of SB 2308, especially since the bill involves state funding.
“As SB 2308 is written, HHSC should not be able to release the $50 million in state funds to the consortium without the private match,” she said.
Last year, Texas Health and Human Services selected UTHealth Houston, in collaboration with The University of Texas Medical Branch at Galveston, to lead a statewide partnership with other universities to conduct a two-year research trial evaluating the effect of ibogaine on patients with addiction, traumatic brain injury, and other behavioral health conditions.
“This landmark clinical trial reflects our unwavering commitment to advancing research that improves lives and delivers the highest standards of care,” said Melina Kibbe, MD, UTHealth Houston president, in a news release at the time.
Harris said the state’s research institutions are capable of managing clinical trials. She said it’s less clear whether the state is willing and able to fully fund the path to FDA approval without private partners.
“A drug development effort like this will likely require much more than $100 million overall, not just the initial $50 million in state funding,” she said.
This article first appeared on The Texas Tribune.
Photo courtesy of Flickr/Scamperdale.
