If the FDA approves psychedelics as a viable treatment option, Alaska – the most sparsely populated U.S. state – stands to reap outsized benefits.
Photo courtesy of Rep. Jennie Armstrong
A bill under consideration in the Alaska State Legislature would create a task force charged with regulating psychedelic therapeutics if they’re approved by the U.S. Food & Drug Administration.
In January, Alaska state Rep. Jennie Armstrong introduced House Bill 228, which calls for the formation of a task force that would “assess the potential use of psychedelic medicine in addressing the state’s ongoing mental-health crisis.”
According to the text of HB 228, the task force also would look at “barriers to implementation and equitable access” and recommend licensing and insurance requirements for practitioners of psychedelic-assisted therapy.
In a March 14 meeting of the Alaska House State Affairs Committee, Armstrong emphasized that the task force “will not consider or take a position on the medicalization, decriminalization or legalization of psychedelic medicines.”
“The purpose is for this task force to create a set of policy recommendations for the next legislature – the 34th – to consider in advance of the almost 99.9%-certain medicalization of certain psychedelic medicines by the FDA so that we can be prepared when that happens,” Armstrong added.
A slide deck that Armstrong prepared for the committee meeting calls attention to Lykos Therapeutics (formerly MAPS PBC), highlighting key milestones in the organization’s quest to gain FDA approval of MDMA-assisted therapy for treatment of PTSD.
In February, the FDA accepted Lykos’s new-drug application and granted the application priority review. Based on the PDUFA timeline, an FDA decision could come in August.
“The reason that this is so important is that the FDA approves about 43 novel drugs ever year, but not all of them have the potential to make as big or an outsized of an impact as this one does,” Armstrong told the committee.
Alaskans Struggling with Mental Health, Addiction
If the FDA approves psychedelics as a viable therapeutic option for PTSD, treatment-resistant depression and other mental-health conditions, Alaska – the most sparsely populated U.S. state – stands to reap outsized benefits.
Alaska has the third-highest suicide rate in the nation, and, for the seventh year in a row, the highest rate of women killed by men, according to data compiled by Armstrong.
Armstrong also asserted that Alaska is reeling from an “addiction crisis,” with 35.6 drug-overdose deaths per 100,000 people.
A bastion for rugged individualists, Alaska is home to the largest concentration of former military personnel per capita in the United States. Alaska’s nine military bases, vast stretches of untamed wilderness and world-class hunting and fishing have made the state a magnet for military veterans.
While that’s a point of pride for Alaskans, it also adds some concerning data points for a state whose residents are struggling with mental health and addiction. Veterans have a 57% higher suicide rate than non-veterans, according to Armstrong’s data, and two out of 10 veterans with PTSD are battling a substance-use disorder as well.
Armstrong noted that the U.S. Department of Veterans Affairs began conducting clinical trials for psychedelics in 2022, adding that “veterans have really led the charge on advocating for psychedelic-medicine treatment.”
While the so-called psychedelic renaissance has been making headlines for several years now – and there’s a mile-long list of clinical trials underway for a range of psychedelic substances – it’s clear that the Lykos NDA, in particular, has lit a fire under Alaska and other states to get their ducks in a row.
“For 20 years they have been running clinical trials for the application of MDMA for PTSD,” Armstrong noted, referring to the work of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which spun off the for-profit MAPS Public Benefit Corporation (now Lykos) in 2014 to commercialize its MDMA therapeutic. The FDA granted breakthrough-therapy designation to MAPS PBC in 2017.
Armstrong pointed to the results of MAPS PBC’s second Phase 3 trial of MDMA, which indicated that 71.2% of participants who received MDMA therapy no longer met the diagnostic criteria for PTSD at the end of the study.
“If anyone here knows anyone who has struggled with mental health, or particularly with PTSD, you understand how extraordinary that is,” Armstrong told the committee. “In a very short period of time, to go from on-the-brink, extreme PTSD to being in remission in just a few months is just unheard of. It’s quite astonishing.”
‘The State Has to Do This Work Anyway’
Given the key role of practitioners in administering MDMA and contributing to successful outcomes, Armstrong asserted that the state needs to establish a licensing structure before FDA approval – which is one of the objectives of HB 228.
“The state has to do this work anyway,” Armstrong said. “We think it’s better to have it be done by a group of very passionate volunteers from across the state from different groups and be prepared so that when this medicine is [approved], we don’t have folks showing up to their doctor saying, ‘I want this,’ and [the doctor saying], ‘Sorry, the state hasn’t figured out licensing yet,’ or, ‘We only have one or two people who are licensed so far.’
“I want to make sure that as many folks as possible have access to this at the same rate as everyone else across the U.S. I want to make sure we’re ready, and to safely maximize these benefits, because I think that it’s going to be huge for our state.”
An April 6 editorial in the Anchorage Daily News echoes many of Armstrong’s comments.
“Due to the high percentage of both active-duty and retired military veterans in the state … as well as the plague of domestic violence … the addition of a new tool to combat mental-health struggles for vulnerable residents could make a huge difference for individual Alaskans and the state as a whole – so long as it’s implemented wisely,” the newspaper’s editorial board declared. “That’s where Rep. Armstrong’s bill comes in.
“If and when the FDA acts to legalize some psychedelic drugs for prescription use, Alaska should be ready. HB 228 would help make sure that’s the case, and surely legislators can carve out a little time from squabbling over the size of the Permanent Fund dividend to attend to the mental-health needs of our veterans and domestic-violence survivors.”