Politics
Louisiana Senate Passes Bill To Create Psychedelic Therapy Pilot Program Funded By Opioid Settlement Dollars
The Louisiana Senate has passed a bill to create a psychedelic-assisted therapy pilot program, using opioid settlement dollars to fund clinical trials aimed at developing alternative treatments such as psilocybin and ibogaine.
The legislation from Sen. Patrick McMath (R) cleared the chamber, with new amendments, in a unanimous vote of 37-0 on Wednesday.
“This concept, this new type of treatment, was brought to my attention by members who served as Navy SEALs and terror rescue men and saw combat and came home and struggled with with post-traumatic stress. And had it not been for this ibogaine treatment that they had to go down to Mexico to receive, they would not be here with us today,” McMath said ahead of the vote. “They would not be fathers. They would not be friends.”
“The results, not only in post-traumatic stress, but also in substance abuse disorder and chronic depression are are overwhelming—over 90 percent success success rate when it comes to both heroin and alcohol dependency,” he said. “Seventeen veterans per day in this country commit suicide. For every combat death, there are five veterans that commit suicide when they come home. If we don’t try to remove some of the regulatory pathways for those folks who sacrificed so much to find peace, then shame on us.”
The bill now heads to the House of Representatives for consideration.
If the legislation is enacted into law, the psychedelics program would be overseen by the Louisiana Department of Health (LDH), which would be responsible for facilitating clinical trials involving substances that hold therapeutic potential. The bill says that eligible participants would include people with opioid use disorders, co-occurring substance use disorders and treatment-resistant neurological or mental health conditions.
Any studies would need to go though the federal Food and Drug Administration (FDA) investigational drug approval process. Researchers would also need to be permitted by the Drug Enforcement Administration (DEA) to conduct trials involving the Schedule I controlled substances.
Patients participating in the studies would need to go through mental and physical health screening, and researchers would also be required to develop processes that ensure safety and compliance, with adverse event reporting rules, training and licensing for therapists and policies for tracking and handling the psychedelics.
There are also specific provisions in the bill (SB 43) concerning ibogaine, with academic institutions authorized to collaborate in the clinical trials to bolster FDA approval prospects to develop prescription drugs based on the psychedelic. Researchers would also be encouraged to collaborate with institutions in other states that have similar programs in place.
If a drug is approved and developed as a result of the pilot program clinical trials, there would be a revenue sharing requirement, with 20 percent of the profits that would go to the state.
Under an amendment previously adopted in committee, Louisiana would participate in a national consortium for ibogaine research and drug development. If an ibogaine therapy does gain FDA approval, revenue tied to the intellectual property rights of that drug would go to the consortium (except for the 20 percent specifically earmarked for Louisiana).
The new amendments the sponsor offered on the floor “make some changes to align the clinical study procedures with best practices” and “remove the fiscal impact to the department,” McMath said.
Last year, the senator also sponsored a resolution approved by the full chamber that called for the establishment of a task force to study and make recommendations on the potential therapeutic benefits of psychedelics for veterans.
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Separately, the Senate also recently passed a bill to let patients with terminal and irreversible conditions use medical marijuana in hospitals.
Meanwhile in the state, another Louisiana lawmaker recently introduced a bill to create an adult-use marijuana legalization pilot program in the state to determine whether the reform should eventually be expanded and permanently codified.
Rep. Candace Newell (D)—who has long championed legislation to end cannabis criminalization and filed a similar legal marijuana pilot program measure last session—is sponsoring what’s titled the “Adult-Use Cannabis Pilot Program Regulation and Enforcement Act.”
Getting the bill across the finish line could prove complicated in the conservative legislature, however. Newell’s earlier version of the pilot program legislation didn’t advance to enactment last year, and lawmakers that session also rejected other marijuana reform proposals such as one that would have established a tax system to prepare the eventual legalization of adult-use cannabis.
Image courtesy of CostaPPR.
