The resumption of clinical research with psychedelics is producing preliminary evidence of benefit for a variety of conditions. These include depression, substance abuse and palliative care. Some research also indicates efficacy in attaining quasi-clinical goals such as “mystical-type experiences.” With proper safeguards in place, the frequency and severity of adverse effects are acceptable. These safeguards include careful screening and preparation of subjects, close supervision of drug sessions with specially trained therapists, and careful follow-up.
We are now hearing calls to increase psychedelics’ clinical availability; i.e., “legalizing psychedelics.” Michael Pollan’s popular book How to Change Your Mind encapsulates many of the arguments for loosening current regulatory burdens that restrict the drugs’ use to the research setting. But there are some risks as well, and as John Horgan reminds us in his recent blog post in Scientific American, we need to exercise due caution.
Psychedelics currently live in Schedule I of the Controlled Substances Act, which is reserved for drugs with high abuse potential; no accepted medical use; and lack of safety even under medical supervision. The lower schedules, II–V, are for drugs with greater safety and for which medical uses exist, but they’re still highly abusable; they include oxycodone and amphetamine, for example. Schedule III drugs, including low-dose opiates/painkillers such as Vicodin or Tylenol with codeine, and certain cough syrups, are less so. Advocates of rescheduling psychedelics usually recommend placement into Schedule III.
My clinical research with the naturally occurring hallucinogen DMT at the University of New Mexico in the 1990s was the first new federally approved and funded human project with psychedelics in the U.S. in a generation. One of the most difficult hurdles I faced was DMT being in Schedule I. After nearly two years of close work with FDA and DEA, an effective system developed allowing our studies to proceed. My subsequent applications to use psilocybin and LSD were much more quickly and easily approved. The New Mexico project’s success established the current American regulatory framework that has allowed for the current burgeoning of human studies with psychedelics.
Psychedelics possess unique characteristics that do not fit neatly into the criteria used to define schedule placement. Their safety and efficacy exist only within highly structured specialized treatment settings. In addition, desired outcomes depend upon the production of a temporary but profoundly regressed, disorganized and incapacitated state. Outside of that structure, psychedelics are no less abusable, acutely debilitating and liable to result in psychological damage—sometimes severe and unremitting—than they ever were.
It is also important to examine the agendas of those advocating for greater availability of psychedelic drugs for human use. One of the most active organizations is the Multidisciplinary Association for Psychedelic Studies, an advocacy group that is developing a pharmaceutical enterprise involving MDMA, a derivative of methamphetamine that has demonstrated benefit in posttraumatic stress disorder. In this case, anything other than Schedule I will dramatically ease the success of the enterprise.
Likewise, how one understands the psychedelic drug state determines the assessment of risks and benefits, and thus drives recommendations for rescheduling. The Johns Hopkins University research group has been one of the most active in the U.S. over the last 15 years. In his book, Sacred Knowledge, William Richards, the clinical director of Hopkins’ psychedelics research program, refers to the drugs’ “inherent spirituality.” He also publicly advocates for widespread availability of these “entheogenic” drugs in his lectures with titles like “Revelation Now.”
While rarely made so explicit, a certain messianic utopianism does pervade much of the psychedelic research community. Glorifying psychedelics’ benefits and rendering innocuous their adverse effects therefore may explain the Hopkins group’s recent publication of a paper suggesting rescheduling psychedelics into Schedule IV—the most liberal recommendation yet to appear. The most well-known Schedule IV drugs are the benzodiazepines, which include drugs such as Valium. Equating their risks and benefits with those of the psychedelics is clinically untenable and borders on the unethical.
Moreover, veterinarians, nurse practitioners, physicians’ assistants, dentists, orthopedists and, in some states, psychologists, can prescribe Schedule II–V drugs. Making psychedelics readily available through these practitioners is not in the public interest.
We are only now just beginning to understand how psychedelics work. Their extraordinarily potent effects on suggestibility is an area that most likely will help us understand their nearly panacea-like properties. A case in point is how Charles Manson used LSD to cement the pre-existing sociopathic beliefs and goals of his followers in much the same way that psilocybin enhances the meaning of a different set of likewise pre-existing beliefs and goals in those seeking more benign outcomes.
Once my research in New Mexico was underway in 1991, I wrote to Janet Reno, then U.S. Attorney General, suggesting a review of psychedelics’ Schedule I placement. We had demonstrated that DMT could be administered safely under medical supervision, and at the very least demonstrated utility as an effective tool in medical research. While little came of that inquiry, I continue to believe that the creation of a new schedule for psychedelics is the most prudent course.
Such a new category—let’s call it IA—does not deny psychedelics’ abuse potential; that is, effective doses both in the research and naturalistic settings produce severe, but temporary, psychic disequilibrium. At the same time, this new schedule would allow their use for conditions for which the evidence may so far fall short of that required for FDA approval as a “new drug.” In addition, the security requirements established by DEA for possession of psychedelics for clinical research—background checks of those handling the drugs, secure storage, regular inventory, etc.—would be the same as for Schedule I substances.
Most important, only those with specialized training would be allowed to administer psychedelics to humans. This training would be developed by FDA, the clinical research community, experts within the NIH divisions that provide funding and/or whose purview subsumes the relevant conditions: for example, the National Institute on Drug Abuse, the National Institute of Mental Health and the National Institute of Alcohol Abuse and Alcoholism.
This system would be similar to that currently existing for psychologists and psychiatrists becoming certified psychoanalysts, as well as for medical specialists in fields like orthopedics, anesthesiology, neurology or psychiatry. With such a regulatory structure in place, we could finally begin to realize the clinical promise of psychedelic drugs without exposing patients to unnecessary risk. It would also ensure that we maintain scientific rigor, intellectual honesty and high ethical standards as we continue investigating how these drugs produce their fascinating effects.