The approval of MAPS’ MDMA will mark an inflection point in history. Since the advent of the Controlled Substances Act in 1970, placement of a drug in Schedule I has effectively operated like a one-way ratchet. Only two drugs have ever exited Schedule I: Marinol (dronabinol), in 1986; and the fentanyl analogue alfentanil, in 1987. Both left Schedule I shortly after FDA approval.
The exit of MDMA in this regard will likely be no different. Under a recent CSA amendment, the DEA must issue an Interim Final Rule to schedule or reschedule a drug not later than 90 days after the date of FDA approval. Because FDA approval necessarily means a drug has a “currently accepted medical use,” the DEA would have to reclassify the drug into some schedule other than Schedule I when approved by the FDA.
MDMA is different in another important respect, however. MDMA’s reclassification would mark the first true reversal in the CSA’s history. The very reason for its scheduling—a serotonin-dumping propensity to induce feelings of love and trust—would be the same reason for its removal. The drug hasn’t changed, but the scientific evidence and our understanding of what the drug can do in a therapeutic environment has.
A Brief History of MDMA
Merck first developed MDMA before World War I under the name “Methylsafrylamin.” Through the first two World Wars, however, its potential for use as a therapeutic remained unrealized. That changed around the time of Sasha Shulgin’s rediscovery of the compound, and subsequently, in the 1970s, MDMA began being used as an adjunct to therapy. Some estimates the number of therapists who therapeutically used MDMA to be in the thousands and the number of patients to be in the hundreds of thousands.
And then MDMA became a club drug. In places like the Starck Club in Dallas, the drug could be purchased over the counter. This recreational development prompted the DEA to announce in mid-1984 that it would take MDMA off the streets and place it in Schedule I of the CSA—the most restrictive category for drug. This then prompted a legal challenge spearheaded by Rick Doblin’s Earth Metabolic Design Laboratories to challenge the Schedule I placement.
That challenge boiled down to a legal dispute. An element to a Schedule I placement is that a drug have “no currently accepted medical use in treatment in the United States.” Psychiatrist and activist Lester Grinspoon argued that MDMA had an accepted medical use because it was being used in therapy more than sporadically, albeit off-the-books. The DEA, on the other hand, argued the drug had no accepted medical use because it had not been approved by the FDA.
The dispute ended up before the First Circuit Court of Appeals in New England, which split the difference. The court held that the absence of FDA approval did not foreclose a determination that a drug had an accepted medical use or can be used safely under medical supervision. But it stopped short of embracing a looser standard whereby acceptance by the medical community without clinical evidence could be enough to preclude a Schedule I placement.
Later unrelated cases involving cannabis would sharpen the “accepted medical use in treatment” standard further. Essentially, by the late 1990s, the standard requires evidence tantamount to what is needed for FDA approval.
Hence, the Multidisciplinary Association for Psychedelic Studies, which Doblin founded in 1986. MAPS rose from the ashes of these hearings and the Earth Metabolic Design Labs to build the playbook and rigorous scientific evidence needed to remove MDMA—and other psychedelics—from Schedule I.
But While the World Changes, Much Remains the Same
That the move toward medicalization of MDMA and other psychedelics has produced profound changes in public perception need not be said. A bit more than two decades ago, the Oprah Winfrey show portrayed MDMA as a drug that would turn brains into Swiss cheese. A few bestsellers and Netflix specials later, and now, MDMA and psychedelics are seen as the opposite: restorative. Popular culture hails these once verboten substances as miracle medicines capable of healing or treating traumas, anxiety, and other vexing
No doubt, this drift from fear to exuberance is partly due to medicalization and the research that underlies medicalization. Controlled experiments with these compounds have shown them to be relatively safe physiologically, even when not used under medical supervision. The same research has not only shown these compounds to be efficacious for the constipated consciousness, but also can induce religious, transformative experiences. These research findings have proliferated into popular culture. Today, for example, more than one in four have tried a psychedelic.
Despite a shift in public consciousness, without a conscious effort to rethink and revamp some of the regulatory infrastructure that got us to this place, much of the broken system will remain the same. Never mind that medicalization does little if anything to address criminal justice issues, consider the issue of bifurcated rescheduling. In the past, both the DEA and Congress have treated an underlying substance different from an FDA-approved formulation of the substance. Take GHB. When included in an FDA approved formulation such as Xyrem, GHB is a Schedule III drug. But non-FDA approved GHB as an identical molecule, the active ingredient, is a Schedule I drug. Similarly, in 2018, after GW Pharma’s Epidiolex won FDA approval—a drug comprised of CBD—the DEA administratively rescheduled FDA-approved CBD, but not CBD generally. This results in a nonsensical system where it can be more difficult to do approved research with the active molecule than it is to commercially buy a product consisting of that molecule—a situation like cannabis’ today.
Does this make rational sense? Probably not. But it does reinforce a key point. While medicalization of MDMA and other psychedelics may usher in a new public consciousness and flavor of health care, this innovation occurs within a legal and societal framework bent towards furthering the pharmaceutical industrial complex. And on its own, it will do nothing to change the legal and regulatory environment that got us to this terrible place. Rather than bring about structural change, aping pharma ushers into psychedelics all the adornments that go along with conventional medicine: capital raises needed for clinical trials, patents, health insurance—the works. Indeed, one could view medicalization as profoundly counter-revolutionary and be disappointed with the trajectory of the revolution. Rather than rethink the way we envision health and medicine—or at minimum, acknowledge and accommodate other practices—in some ways, medicalization reinforces the status quo and crowds out other holistic ways of thinking about health.
So, whether the psychedelic revolution will be medicalized depends on what you mean by revolution. If a revolution means changing minds about psychedelics, then mission accomplished. Certainly, as well, the rescheduling of FDA-approved MDMA and other FDA-approved psychedelic compounds will change mental health care standards and save lives. But will these developments result in deeper changes in how we view or access medicine? Maybe not, as these innovations have occurred almost exclusively within the conventional pharmaceutical paradigm.
The hope is that this is the first chapter. Medicalization can be seen as a step toward broader legalization, some say, and operates like a desensitization or exposure therapy. As society becomes more exposed and accustomed to these drugs in a controlled medical setting, the theory goes, the stigma surrounding psychedelic use will recede and create a climate more favorable to regulate adult use. While this happened and continues to happen with cannabis, it is important to note at least one key difference: unlike psychedelics, medicinal cannabis played out and developed on a state-by-state basis outside FDA-approval paradigms.
Only time will tell if medicalization bends us toward legalized non-medical access. But even if this scenario were to play out, it wouldn’t be close to overnight. As for me, color me skeptical that the approval of psychedelic drugs as pharmaceutical medicine, within pharmaceutical paradigms, brought to market by companies and nonprofits populated by pharma executives will alone catalyze structural change in drug regulation. Medical research has gotten far. But for a true revolution to occur, there needs to be strong will, definite intent, and hard work beyond research and development. Going forward, it is as important to support the research as the organizations parlaying that research to bring about sensible, substantive, structural reforms at both federal and state levels.regulation controlled substances act fda research legalization legalized psychedelics psychedelic mdma
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