Creating a field of psychedelic medicine opens the window to potential benefits and risks by increasing their accessibility. Rescheduling psychedelics out of the highly restrictive Schedule I is necessary for this to occur. Additional issues of public health policy must be determined, and who takes the lead in shaping these policies requires careful attention.

Momentum is building to carry outside of the ivory tower biomedical research’s positive and measured, yet preliminary, findings of psychedelics’ benefit for a number of conditions. This goal is generally referred to as creating “psychedelic medicine” or establishing “psychedelics as medicine.” Medicine, more-or-less different than, but still falling within the realm inhabited by, any other medicine. This momentum has been moving forward through the successes wrought through strict adherence to the biomedical model, and levelheaded relationships with the media. We see double-blind, placebo-controlled trials, statistically demonstrable biological and psychological data, minimal if any media grandstanding, manageable doses, and a politically correct rendering of adverse effects into challenging experiences. I have covered each of these in previous posts.

The potential benefits and risk associated with this movement are highly correlated.

An ever-increasing number of disorders have demonstrated positive responses to rigorously structured clinical research protocols; the strongest data being for depression, obsessive-compulsive disorder, alcohol or tobacco dependence, and end of life issues. A non-clinical indication with good data is the enhancement of one’s spiritual practice. Less robust data exist regarding eating disorders, reducing criminal recidivism, a deeper appreciation of music and nature, reduced psychosis, and post-traumatic stress disorder. In the last case, I’m referring to the strong data indicating a benefit of MDMA—a non-classical drug.

Federal Food and Drug Administration regulations describe how to get a new drug approved for mainstream use. This is the familiar Phase 1, 2, and 3 process. MDMA and psilocybin are furthest along in this regard. It is also possible in exceptional cases to permit wider use a new drug outside of the strict research setting if relatively good data exist and there are few or no other viable treatment options.

Advantages: With greater accessibility for more indications, a new treatment may feel less experimental, garner wider acceptance, and be associated with less stigma. Theoretically, such work taking place in broad daylight would also provide more data—positive or negative—regarding utility in the real world.

Risks revolve around the same issues. Practitioners may overreach legitimate indications; and treat a clientele less well screened, diagnosed, prepared, supervised, and followed up. These are all key ingredients in the successful and safe outcomes seen in the series of studies now taking place. In addition, greater scrutiny will result from more widespread clinical use of these drugs. Breitbart might camp out on the clinic lawn, and TMZ may track down disgruntled clients. How will we respond to such increased visibility?

The stem-cell clinic phenomenon comes to mind, as much as I try to push it out. Or brain-imaging clinics promising biologically tailor-made diagnoses and treatment for psychological and psychiatric disorders. These clinics, based on more-or-less sound data and/or more-or-less financial self-interest, may do varying degrees of harm by overstating their claims. In the case of the wider availability of psychedelic medicines, understatement, under-claiming, and a minimal media footprint will go a long way. So will adherence to research protocols to the extent possible.

Who would be the practitioners within this novel setting? The opening up of “psychedelic medicine” ought not be a license for anyone with an interest in psychedelics to claim hegemony and/or expertise. “I took a lot of psilocybin,” or “I studied with a Shipibo shaman for 6 months” are not enough. Training requirements should be rigorous, focused, and time-consuming. Clinical directorships are best vested in specially trained and certified psychiatrists. Constant peer-review and re-certification of all practitioners should be mandatory.

What will be such clinics’ philosophy and practice of treatment? While approaches may broaden out from the secular, nearly manual-driven protocols now taking place, such broadening ought to be modest. Licensing of non-research settings should not be interpreted as opening the floodgates to the shamanic or the religious. I say this with full disclosure of my interest in a more religiously-oriented approach to the spiritual use of psychedelics. However, neither the shamanic nor traditional religious models for using psychedelics possess the data-driven legitimacy that biologically- and psychologically-oriented ones do. And the “mystical-like,” nearly secular, inner-oriented spiritual platform generates a much less visceral reaction than do shamanism or traditional Western streams.

Mainstreaming psychedelics by increasing their accessibility requires lowering their schedule from the current hyper-restrictive Schedule I. No-one can administer a Schedule I drug to humans outside of FDA- and DEA-approved research. On the other hand, most medical practitioners—any physician, veterinarian, or dentist—routinely possess DEA permission to prescribe drugs within Schedules III-V. Without too much difficulty, any practitioner can obtain a Schedule II permit, allowing the prescribing of drugs like cocaine, methamphetamine, fentanyl, Dexedrine, and OxyContin. Schedule III drugs include anabolic steroids, certain barbiturates, ketamine, and low doses of low potency opioids such as codeine. The benzodiazepines reside in Schedule IV.

Most proposals regarding rescheduling psychedelics as clinical medications suggest dropping them to Schedule III in which case those who wish to prescribe them will require particular certification. However, it appears more prudent that the increased availability of these drugs occur as slowly as possible. This, in order to work out the details and consequences of greater accessibility, rather than scrambling after the case to rein in use that got ahead of itself, beyond the data and less than convincingly safe. Schedule II also seems too lenient, as any veterinarian or dentist, dermatologist or radiologist, expending minimal effort, could obtain such a higher-level license and prescribe as he or she sees fit.

I have suggested several times previously the consideration of a new schedule: Schedule IA. Such a novel category of drugs requires a novel category of scheduling. Small numbers of such permits would be issued, and training, supervision, and reporting standards of and by practitioners would proceed at a cautious pace.

Who will determine these policies? It is worth noting the background and credentials of those who are leading the movement to medicalize psychedelics. The major organizations are: the Council on Spiritual Practices led by a former Oracle software designer; the Multidisciplinary Association for Psychedelic Studies led by a PhD in public policy; the Beckley Foundation led by an English countess who garnered attention drilling holes through her skull; and the Heffter Research Institute led by a former professor of medicinal chemistry and pharmacognosy. No physicians, and no one with clinical experience.

Here is an example of how a lack of clinical experience might backfire when proposing public health policy regarding psychedelics. This is the notion of re-scheduling psychedelics into a category like mifepristone, the emergency abortion pill. Only special pharmacies carry it and only certain physicians can prescribe it. This seems reasonable until considering that mifepristone is given by the pharmacist to the patient who takes it home with her. The effects are endocrinological and not psychedelic. In addition, equating birth control with psychedelics, in any manner, may alarm patient advocates of both religious and non-religious persuasions, and meet with some skepticism by regulators.

I have known all of the heads of these organizations for up to 30+ years, have the highest respect for their integrity and intelligence, and count them among my friends and professional colleagues. They and their organizations have moved the field forward light years by advocating for research; and helping design and fund the execution of others’ clinical studies. But they have no hands-on clinical experience—neither human research nor treating patients.

I believe that lacking medical and clinical expertise limits the validity of these organizations’ leaders’ perspectives on the real world of clinical medicine. This is the world in which they wish to see these drugs establish a position as a legitimate treatment. Here is a case where one cannot have it both ways. That is, seeking to determine policy for psychedelics’ medicalization without the medical background necessary for laying out their safest and optimal use within that biomedical setting.

I hope that responsible federal and medical regulatory bodies are not swayed by undue enthusiasm for a novel treatment with so-far extraordinarily promising results. The field had lain fallow for nearly a generation before this current renewal of interest. Therefore, policy changes in the direction of greater availability for psychedelics should be incremental, informed and determined by criteria of impeccable clinical and public health standards by those most qualified to do so.

 

 

 

 

 

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