The Food and Drug Administration seemed poised to approve MDMA (3,4-methylenedioxymethamphetamine, a/k/a molly or ecstasy) PTSD treatments by mid-2024, but a recent report may derail the approval process.
Proponents hope the efforts could yield the first major new therapies for mental illness since the introduction of modern antidepressants in the 1980s. But not all researchers are convinced that their benefits have been validated, or properly weighed against the risks. And they can be difficult to assess using traditional clinical trials.
The first MDMA-assisted assisted therapy appeared to be on track for FDA approval this August, but a recent report from an independent review committee challenged the integrity of the trial data from the drug’s maker, Lykos Therapeutics, a startup founded by a psychedelic research and advocacy group. The FDA will convene a panel of independent investigators on June 4 to determine whether to recommend the drug’s approval.
Proponents of the new therapies also worry that the FDA will impose treatment protocols, such as requiring multiple trained clinicians to monitor a patient for extended periods, that will render them far too expensive for most people.
The MDMA-assisted therapy included three eight-hour medication sessions overseen by two therapists, each followed by an overnight stay at the facility and an integration session the following day.
Considering everything, “it does seem that some of these molecules can be administered safely,” said David Olson, director of the University of California-Davis Institute for Psychedelics and Neurotherapeutics. “I think the question is can they be administered safely at the scale needed to really make major improvements in mental health care.”
The Nature of PTSD
Mental health issues are slowly but surely losing their “s/he can’t take it” labels and making their way alongside physical health issues as treatable conditions. Post Traumatic Stress Disorder is riding this wave.
For many years (many centuries actually, since the first PTSD episodes were recorded among Assyrian soldiers around 1300 B.C.), PTSD was the classic “s/he can’t take it” misunderstood mental illness.
Combat-related PTSD moved to the forefront during World War I. The men who served were not prepared for what were for them terrifying new weapons like poison gas and machine guns. Despite the huge number of “shell shock” cases, doctors never looked for a common denominator or chemical cause.
Stay with us here, but the Rambo films reflect an evolving public opinion about PTSD. In 1982’s First Blood, John Rambo was a mindless PTSD monster. Outside the opening scene and a monologue at the end of the film, Sylvester Stallone only had about a dozen lines. By 2019’s Last Blood, Rambo had progressed to a Fisher King-like hero who struggled with a medical condition.
That medical condition is a stress-induced enlargement of the amygdala (the part of the brain that controls emotional functions) The larger amygdala crowds out the hippocampus (logical responses). So, PTSD symptoms include:
- Hypervigilance,
- Depression,
- Anger,
- Nightmares, and
- Flashbacks.
Based on this medical evidence, the Canadian Armed Services has replaced PTSD with OSI (Operational Stress Injury), an injury that qualifies for Canada’s version of the Purple Heart.
PTSD and Psychoactive Drugs
Although it has a chemical cause, a chemical solution for PTSD remains elusive. The few PTSD drugs available have usually been on the market for at least twenty years. Many researchers hope that psychoactive drugs might be the breakthrough many PTSD patients need.
The common category of antidepressants often used to treat PTSD now are Selective Serotonin Reuptake Inhibitors (SSRIs). These drugs work by increasing the amount of serotonin available to bind to serotonin receptors in the brain. Serotonin is a neurotransmitter that helps regulate your mood. When more serotonin binds to specialized receptors, it may help patients feel more stable and content.
Psilocybin also acts on serotonin receptors, but scientists say the drug’s impact reaches far beyond serotonin. They believe that the drug actually alters the way neurons connect to one another. “We’re talking about a different mechanism of action that these drugs have compared to the old serotonergic compounds,” one researcher said. “The mechanism of action doesn’t rely on one molecule.”
Furthermore, psychedelic drugs seem to induce a state of plasticity that can make it easier for people to rewire neuronal circuits and learn new things, like they did when they were kids, for example. That provides the opportunity for therapy to be especially effective. Patients are more likely to embrace new connections and ways of thinking during their treatment.
For other doctors, the proof is in the pudding. One controlled dose of MDMA eases anxiety, the root of most PTSD symptoms, for months at a time.
Despite the aforementioned changed attitude, progress in this area has still been slow, mostly because the U.S. government outlawed MDMA and other psychedelic drugs in the 1960s, and studies are limited.
Does the Defense Base Act Pay for Experimental Treatments?
Absolutely, if these experimental treatments are available in a given area, and if the treatment clears the reasonably necessary hurdle.
Regional availability is a big issue in these cases. Doctors in New York often embrace experimental therapies, but good luck finding such a doctor in Nebraska. Additionally, psychedelic PTSD treatments are more widely available in foreign countries like The Netherlands, where psychedelic drugs are at least semi-legal.
As a side note, marijuana helps some PTSD patients get better, but this drug is not psychedelic, so we will cover its effect on PTSD in another blog.
As another side note, PTSD victims should not self-medicate with psychedelic or party drugs. We understand the temptation to do so, because the aforementioned PTSD symptoms are usually crippling. However, uncontrolled self-medication, with drugs or alcohol, just makes a bad problem worse. PTSD is treatable, but PTSD combined with substance addiction or another health problem is essentially untreatable.
Back to the point we were trying to make. The Defense Base Act might pay for experimental treatments, but it usually doesn’t pay for transportation expenses in these cases. If victims want to travel to Holland, they must normally do so on their own dimes.
Additionally, the DBA only pays for experimental PTSD and other medical treatments if a Defense Base Act lawyer proves those treatments were reasonably necessary.
Reasonably necessary has two basic components, cost-effective and medically appropriate. There is a difference between cost-effective and cheap. The large box of Ruffles at Sam’s costs more than the small bag, but on a per-chip basis, the large bag is cheaper. Treatments are medically appropriate if they have some scientific basis, they have been successful in the past, and the victim gets better. Psychedelic drug PTSD treatments check all three of these boxes.
For more information about DBA eligibility, contact Barnett, Lerner, Karsen, Frankel & Castro, P.A.