
- Vol 40, Issue 1
Keep the Cart Behind the Horse: Privilege and Responsibility as a Provider
Remember to keep the cart behind the horse while practicing medicine.
The privilege of practicing medicine is accompanied by immense responsibilities. Medicine is an imperfect profession, as all human professions and actions are imperfect, and our current treatments are the result of hundreds of years of trial and error that inherently produce results that are at times spectacularly successful or eventually reveal pain and suffering. Antibiotics come to mind as a paradigm-changing benefit to the treatment of infectious diseases. Anesthesia modernized surgery with dramatic benefits for the patient. However, some of our treatments, although initially believed to be safe and effective, ultimately were found to cause significant harm in some patients (Table 1).
To maximize positive clinical outcomes and minimize harm, we as health care providers undergo rigorous medical education and supervision, which culminates in a license to practice. Practice is indeed the correct verb in medicine, as we never perfect our learning and clinical acumen. Medicine is a constant work in progress, with some established dogmas of the past falling by the wayside as our understanding forges ahead with new discoveries and treatments. As such, it is our responsibility to educate and reeducate ourselves about our armamentarium of medications, especially when considering their therapeutic worth. As the
Over the past several years, psilocybin, 3,4-methylenedioxymethamphetamine (MDMA), and esketamine/ketamine have become common topics of conversation throughout the United States in a casual manner that lacks the context needed to understand their current or possible future role in routine psychiatric practice. Without the guardrails of evidence-based medical research, submission for US Food and Drug Administration (FDA) approval, and (if approved) Drug Enforcement Administration (DEA) scheduling, these drugs have the potential to cause significant harm. Equally important, medical professionals must become educated about their established clinical benefits before these guardrails have been implemented. Only then can an ethical discussion about their potential benefits, risks, and adverse effects occur without a clinician’s personal biases intruding and contaminating a patient’s understanding.
There is nothing special or unique about ketamine,
In many instances, drugs that are now regulated by the DEA as controlled substances, or that have been deemed illegal and classified as Schedule I, were once readily available from numerous sources. Cocaine and opium are 2 classic examples. Cocaine, a Schedule II drug, is actually legal to prescribe in an emergency department setting. Opium served as the progenitor to the vast array of µ-opioid receptor agonizing analgesics that became the backbone for pain management until recently. (Interestingly, the alarm is due to overprescribing, unintentional addiction resulting from opioid tolerance, and a rapidly escalating US death rate from
Alcohol and Tobacco
All drugs are not dispensed and administered by health care professionals. Two of the drugs with the highest contributions to mortality in the United States are regulated by the US Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau:
Our goal, thus, should be to help prevent and address the abuse of these 2 drugs among our patients.
Esketamine
Intranasal esketamine—1 of the 2 active isomers of
Psilocybin
Psilocybin is undergoing phase 3 clinical trials for
Furthermore, the clinical trials with psilocybin involve comprehensive treatment protocols that are as integral a part of the treatment intervention as the
Findings from a recently completed phase 2 double-blind trial of psilocybin for treatment-resistant depression demonstrated a potential complex treatment protocol.4 Study participants were outpatients experiencing a depressive episode who met criteria for treatment-resistant depression, with documentation of nonresponse to 2 to 4 adequate antidepressant trials. The individuals were randomized in a double-blind ratio of 1:1:1 to receive psilocybin doses of 25 mg, 10 mg, or 1 mg (control group). During a 3– to 6–week run, all antidepressants were tapered and discontinued by 2 weeks before the actual trial began. This time included at least 3 sessions with a therapist for psychoeducation, preparation for the psychedelic experience, and to build trust.
On day 1, the participants received their randomized dose of psilocybin and spent 6 to 8 hours in a calm and nonclinical treatment room, wearing eyeshades, and listening to a specific music playlist in the presence of the lead therapist and an assistant therapist. Two integration sessions occurred with the same therapist on days 2 and 7. The study participants were followed and evaluated for 12 weeks after their single dose of psilocybin. The primary outcome was change from baseline (the day before receiving the psilocybin) to week 3 in the Montgomery-Asberg Depression Rating Scale (MADRS) score. The 25 mg but not the 10 mg dose demonstrated a significant improvement in MADRS score compared with the 1 mg dose at 3 weeks.
MDMA
Based on the robust outcomes in phase 2 and 3 studies, it is likely that
Currently, psilocybin and MDMA are both Schedule I drugs in the United States, making them illegal and characterized by the Controlled Substances Act as having “no currently accepted medical use and a high potential for abuse”—qualities that ongoing preclinical studies are calling into question. Despite this, both drugs have been granted breakthrough therapy designation by the FDA. The Schedule I status creates a huge obstacle for researchers and serves to significantly slow down potential advances in research. On November 17, 2022, US Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced the Breakthrough Therapies Act, which would allow the DEA to reclassify a Schedule I drug as Schedule II if the drug was granted breakthrough therapy designation status by the FDA based on established preclinical research.8
Concluding Thoughts
As health care providers, we must refrain from non–evidence-based treatment, especially when it involves Schedule I drugs.
Understandably, there is a lot of excitement from clinicians and patients alike about the possibility of future FDA approval of MDMA-assisted therapy for severe PTSD and psilocybin protocols for treatment-resistant depression—2 diagnostic categories with a huge unmet need for novel and improved treatments. Most competent and ethical health care providers would not recommend their patient have ethanol-assisted or tobacco-assisted treatment for their PTSD or depression, despite these drugs being legal and nonscheduled by the DEA. For clinicians who work in a state where cannabis is legal, I would not recommend THC-assisted therapy. As competent and reproducible clinical research data accumulate on the possible psychiatric applications for psilocybin and MDMA, we must nurture our patience.
Reflecting on a good piece of advice, let’s keep the cart behind the horse.
Dr Miller is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief, Psychiatric Times™; Staff Psychiatrist, Seacoast Mental Health Center, Exeter; Consulting Psychiatrist, Exeter Hospital, Exeter; Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts.
References
1. Esser MB, Leung G, Sherk A, et al.
2. Miller JJ.
3. ClinicalTrials.gov. Accessed November 3, 2022.
4. Goodwin GM, Aaronson ST, Alvarez O, et al.
5. Mitchell JM, Bogenschutz M, Lilienstein A, et al.
6. Jerome L, Feduccia AA, Wang JB, et al.
7. Feduccia AA, Jerome L, Yazar-Klosinski B, et al.
8. Booker, Paul introduce bipartisan legislation to promote research and access to potential lifesaving drugs. Cory Booker. News release. November 17, 2022. Accessed November 22, 2022.
Articles in this issue
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Daniel M’Naghten: The Man Who Changed the Law on Insanityover 2 years ago
Insights From the 2022 AAPL Annual Meetingover 2 years ago
Abortion and the Psychiatrist: Practicing in Post-Dobbs Americaover 2 years ago
Navigating Legal Complexities in Psychiatric Practiceover 2 years ago
Individualizing Treatment Options in BDIover 2 years ago
If You Ask Me My Nameover 2 years ago
AMA President Addresses the State of Medicineover 2 years ago
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