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The National Defense Authorization Act of 2024 has been signed into law by Joe Biden
Greece, New Zealand, and Hong Kong have a smaller combined Gross National Product than the gargantuan, 886 billion dollar, 2024 US Defense budget. Nevertheless, the National Defense Authorization Act of 2024 was passed by both the House and the Senate and signed by President Joe Biden. Perhaps the best part of the bill is tucked between sections with mundane titles such as "Modification of special and incentive pay authorities for members of reserve components" and "Amendments to multiyear procurement authority." It's referred to as the Douglas "Mike" Day provision. This will allow active-duty military personnel to participate in psychedelic-assisted clinical trials to address post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and chronic traumatic encephalopathy (CTE). It means that help is on the way at least for some.
"We have all suffered or will suffer trauma, and it will continually happen until
we leave this place."
Navy SEAL Senior Chief Douglas "Mike" Day is known for his heroic deeds in Iraq and for his inspiring story of perseverance. In 2007, he was shot 27 times during an encounter with al-Qaeda in the city of Fallujah. Incredibly, he survived the bullets as well as a devastating grenade blast. Later, he was diagnosed with post-traumatic stress disorder and traumatic brain injury. Still, during the ensuing years, he worked as an advocate for wounded service members and for those living with PTSD. In 2020, he vividly chronicled his experiences in the book, Perfectly Wounded: A Memoir About What Happens After a Miracle. On March 27, 2023, Mike Day took his own life.
The Mike Day provision of the NDAA will allow for the appropriation of 15 million dollars each year between 2024 and 2028 to facilitate clinical trials. The psychedelic substances that can be used in these trials includes: 3,4-methylenedioxy-methamphetamine (better known as MDMA or ecstasy), psilocybin (or "magic mushrooms"), ibogaine (a psychoactive substance found in the iboga plant which is native to Africa), and 5–Methoxy-N,N-dimethyltryptamine (5–MeO–DMT is a tryptamine that occurs naturally in some plants and is secreted by the glands of a species of toad).
Origins of the Mike Day Provision
Credit for drafting and pushing this provision forward in the US Congress belongs to two House representatives that are both former Navy Seals from Texas, Representative Dan Crenshaw and Representative Morgan Luttrell. Representative Crenshaw authored the Douglas 'Mike' Day Psychedelic Therapy to Save Lives Act. Representative Luttrell worked the provision into the NDAA.
"Why am I pushing for this? Because it works. And as Mike’s widow Brenda would attest to, it could have saved Mike’s life," Representative Crenshaw said, referring to Mike Day – the namesake of the bill.
“I was honored to see several of my amendments and priorities accepted into the final version of the bill, including clinical trials on psychedelic therapy to treat PTSD," said Representative Luttrell.
About PTSD
All of our brains are equipped to respond to traumatic situations with a kind of alarm system. It helps us to survive difficult events like accidents, war, abuse, and various forms of violence. With PTSD, the alarm system becomes super sensitive and memories of the traumatic event are easily and often triggered. Those memories, playing over and over on a loop, are thought to reside in the amygdala portion of the brain. Other issues, ranging from anxiety to suicide, are sometimes manifestations of trauma as well.
Research indicates that approximately 14% to 16% of the US service members deployed to Afghanistan and Iraq have been affected by PTSD or depression. Gates MA, et.al. (2012) y Ling Liu, et. al. (2019)
Over 6,000 veterans die by suicide each year (Nichter, et al. 2020).
"The prevalence of combat-induced PTSD is between 2% and 17% in US veterans." (Inoue, et al. 2023)
“Hope is being able to see that there is light despite all of the darkness.”
-Desmond Tutu
About TBI
"Traumatic Brain Injury (TBI) may result from anywhere between a simple blow to the head to a penetrating injury to the brain. In the United States, around 1.7 million people suffer TBI with older adolescents (ages 15 to 19 years) and older adults (ages 65 years and older) among the most likely to sustain a TBI. The frontal and temporal areas of the brain are the main areas involved. Mild TBI (mTBI), also known as brain concussion, initially considered as a benign event, has galvanized tremendous attention for some of its adverse neuropsychological outcomes in civilians (e.g., athletes who play contact sports) as well as military personnel. Moderate to severe TBI is a primary cause of injury-induced death and disability. In the United States, It has an annual incidence of approximately 500 in 100,000. However, around 80% of all TBI cases are categorized as mild head injuries." (Georges et al. 2023)
About CTE
"Millions of people worldwide get repetitive head impacts through various activities. These can lead to chronic traumatic encephalopathy (CTE), a progressive neurodegenerative disease that causes brain damage similar to that seen in Alzheimer’s disease. CTE has been reported in people as young as 17. The incidence of CTE in young people, however, is unknown.
"An NIH-funded research team, led by Dr. Ann McKee at Boston University and VA Boston Health Care, analyzed 152 brains (141 male and 11 female) that were donated to a brain bank. The brain donors had a history of repetitive head impacts from playing contact sports and were younger than 30 years old when they died. Researchers examined the brains and surveyed the donors’ next of kin about clinical symptoms. Results were published in JAMA Neurology on August 28, 2023.
"More than 40% of the donors (63 out of 152) had CTE based on established criteria. Nearly all cases of CTE were mild (stages 1 or 2 out of 4). Donors with CTE tended to be older than those without the disease. The most common cause of death among the donors was suicide, followed by unintentional drug overdose. The causes of death did not differ between those with and without CTE. Most of the donors with CTE were male, but one was female—a collegiate soccer player." (Brian Doctrow, National Institutes of Health report 2023)
Progress in Clinical Trials
In a 2022 study, reported by Mitchell et al. (2023),104 participants with moderate to severe PTSD were initially recruited. However, nine participants withdrew before the study concluded. Of the 95 participants who completed the study, 52 were given MDMA-assisted therapy and 43 received a placebo (one participant from the placebo group was excluded from the final results). The results showed that, with three treatment sessions, 45 of 52 (86.5%) of the MDMA-assisted therapy group participants experienced “clinically meaningful improvement” (as specified by the study’s protocol) during the 18-week period after beginning the treatment versus 29 of 42 (69%) participants from the placebo-assisted therapy group. By the end of the study in November 2022, 37 of the 52 (71.2%) participants from the MDMA group no longer met the criteria for PTSD, versus 20 of the 42 (47.6%) participants from the placebo group. At the end of the study, 24 of the 52 (46.2%) participants in the MDMA group met the criteria for remission, versus 9 of the 42 (21.4%) participants in the placebo group. In this study, neither the participants nor the researchers knew who received or did not receive the MDMA- or placebo-assisted therapies (The Psychedelic Blog) This is just one of dozens of clinical trials now underway in all parts of the world.
How do psychedelics work?
Neuroscientist Gül Dölen at Johns Hopkins University School of Medicine studies how MDMA, or ecstasy, facilitates the treatment of PTSD by reactivating a "critical period" in the brain, during which it is more receptive to learning the rewards of social behaviors. This effect may strengthen the bond between psychotherapist and patient, making it easier for patients to form positive associations and process traumatic experiences. MDMA achieves this by influencing the brain's response to something called, oxytocin, the "love hormone," which enhances learning and memory related to social rewards. This reopens the critical period only in social settings, suggesting its dependency on social interactions for efficacy.
“For the first time we find that psilocybin works differently from conventional antidepressants – making the brain more flexible and fluid, and less entrenched in the negative thinking patterns associated with depression,” concluded David Nutt, DM, head of the Imperial Centre for Psychedelic Research. (OpenAccessGovernment.org)
Right now, there is research that exists with veterans, but no real data on the active-duty population (for early stage PTSD and TBI). These trials could advance our understanding of the potential benefit of breakthrough therapies early on. Whatever the outcome may be, here's hoping that active-duty military can find relief as a result of these groundbreaking trials.
-robert j. benz, The Psychedelic Blog
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