By Kathryn L. Tucker, JD*
Recent medical research is establishing the powerful therapeutic uses of psilocybin in the treatment of anxiety and depression suffered by patients with terminal illness, as well as other possible indications. Studies show that patients with advanced cancer suffering from treatment-resistant anxiety and/or depression experienced significant reductions in both anxiety and depression and improvements of mood following a single, guided treatment with psilocybin, with no safety concerns or clinically significant adverse events.[1]
This is important because people with late-stage terminal disease endure suffering to a greater extent than those in the general population.[2] Dying patients frequently suffer depression and anxiety,[3] which can lead to earlier death. [4] Anxiety is the most common reason for psychiatric consultation among terminally ill cancer patients; in addition to potentially resulting in earlier death, it causes lower quality of life, increased levels of insomnia, decreased trust in physicians and poor treatment compliance.[5]
Despite the clear promise of psilocybin to address anxiety and depression in dying patients, it is not available. It is classified as a Schedule I drug regulated by the federal Controlled Substances Act.[6]Accordingly, it cannot be prescribed by a physician, it is not legally accessible to those who might benefit from it as a therapeutic treatment.
Oregon’s recently adopted Measure 109, the Oregon Psilocybin Services Act(“PSA”), will make psilocybin in a therapeutic setting legal under Oregon state law.[7] The PSA establishes a two year ‘development program’ for development of regulations by the Oregon Health Authority (OHA), advised by a Psilocybin Advisory Board established within the OHA. Regulations governing the manufacture, transportation, delivery, sale and purchase of psilocybin products, and the provision of psilocybin therapy services, will be developed in this 2 year period. Therapy must take place with a trained and licensed psilocybin therapist at a licensed psilocybin services facility, and must consist of a preparation session, an administration session, and an integration session. Licensees are exempt from the criminal laws of Oregon for possession, delivery or manufacture of psilocybin, aiding and abetting another in the possession, delivery or manufacture of psilocybin, or any other criminal offense in which possession, delivery or manufacture of psilocybin is an element. Terminally ill patients with anxiety and depression would be among those able to access psilocybin therapy under the proposed measure.
Prominent palliative care physicians have spoken out in support of psilocybin therapy. Former president of the Academy of Hospice and Palliative Medicine, Dr. Ira Byock, has observed: “Results suggest that therapy with psilocybin is well tolerated by seriously ill patients and, for some, remarkably effective in alleviating non-physical distress. . . . [T]herapeutic benefits often persist long after any pharmacologic effect of the drug.”[8] Dr. Byock urges that “it is time to revisit the legitimate therapeutic use of psychedelics.”[9] End of Life advocacy groups have adopted policy supportive of access to psilocybin therapy for patients with advanced illness.[10]
The efficacy of psilocybin in relieving anxiety and depression in terminally ill patients is especially important in light of the fact that efforts of the past quarter-century to enhance palliative care for the terminally ill have yielded significant progress in reducing physical pain and discomfort.[11] However, little progress has been made in helping patients reduce anxiety or depression about, or come to terms with, the psychological and existential issues raised by impending death. Psychotherapy facilitated with psilocybin offers an additional palliative care tool to improve the wellbeing of terminally ill patients by mitigating psychological distress.
Oregon is no stranger to enacting alternative options for the terminally ill: With the passing of the Death with Dignity initiative in 1994, Oregon became the pioneer nationwide in empowering dying patients with the option of aid in dying(“AID”) and has maintained an open practice of AID since implementation began in 1998.[12]
AID refers to the practice of a physician providing a mentally competent, terminally ill patient with a prescription for medication that the patient could ingest to achieve a peaceful death and avoid further suffering.[13] In the debates leading to the passage of the statutory permissions for AID, virtually all voices emphasized the need to ensure that eligible patients were provided with excellent and effective palliative care, so that no patient was motivated to choose to precipitate death due to inadequate pain and symptom management.[14] Adding another intervention to the “tool box” of palliative measures available to terminally ill patients should be particularly welcome in Oregon, and other states that permit AID. Since these states already empower dying patients with both the option of eradicating consciousness via palliative sedation and advancing the time of death via AID, it is reasonable to allow these patients access to psilocybin for relief of anxiety and depression.[15]
Even though the PSA passed, psilocybin will remain illegal under federal law, unless rescheduled. Until that occurs, it is possible that a form of “cooperative federalism” could arise with regard to psilocybin use in Oregon.[16] This is a policy where the federal government refrains from taking prosecutorial action if state law permits use. The shelter provided by this approach depends on the policy of the U.S. Department of Justice, which can change as the political winds or office holder changes—as was the case with cannabis.[17]
There is a possible alternative avenue to access psilocybin therapy for patients with life-threatening illness, provided in both state and federal law: Right to Try (“RTT”) Acts “allows use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law,” barring federal prosecution for manufacturing, prescribing, and dispensing medications to such patients where certain conditions are met.[18] Under RTT, therapeutic use of psilocybin with patients with “a life-threatening disease or condition,”[19] is protected because psilocybin meets the requirements to be deemed an “eligible investigational drug,”[20] as it has completed Phase I clinical trials and remains under investigation.[21] Hence, terminally ill Oregonians suffering from anxiety and/or depression ought be able to legally access psilocybin therapy apart from and before implementation of the PSA.[22] A case seeking to establish that access to psilocybin for therapeutic purposes under RTT is protected has been filed. AIMS et al v DEA (filed March 8, 2021, CA9 21-70544)
Conclusion
Psilocybin appears to offer clear benefit to alleviate anxiety and depression suffered by those with terminal illness. Oregon adopted Measure 109 in November 2020, making psilocybin therapy legal under Oregon law. However, access to such therapy under the PSA will not be permitted before 2023; even then question will remain with regard to federal exposure. It is possible that access under Right to Try can begin sooner than the PSA permits, with safe harbor under both state and federal law.
* Kathryn L. Tucker, J.D., is Special Counsel at Emerge Law Group. She is also Executive Director of the End of Life Liberty Project, dedicated to protecting and expanding the rights of the terminally ill, which she founded during her tenure as Executive Director of the Disability Rights Legal Center, a leading disability rights advocacy organization. Previously, Tucker served for two decades as Director of Advocacy and Legal Affairs for Compassion & Choices, engaging multidimensional advocacy to improve care and expand choice at the end of life. Prior to that, she practiced law with Perkins Coie. She has held faculty appointments at Loyola Law School, Los Angeles, the University of Washington School of Law, Seattle University School of Law, and Lewis & Clark Law School, teaching in the areas of law, medicine, and ethics pertinent to the end of life. Tucker currently represents the physician and patients in the case discussed herein, AIMS et al v DEA (filed March 8, 2021, CA9 21-70544). Ms. Tucker can be reached at kathryn@emergelawgroup.com.
[1] Charles S. Grob et al., Pilot Study of Psilocybin Treatment for Anxiety in Patients with Advanced-Stage Cancer, 68 Arch Gen Psychiatry 71, 71 (2011) (anxiety levels measured at one, three, and six months after treatment “demonstrated a sustained reduction in anxiety”); Roland R. Griffiths et al., Psilocybin Produces Substantial and Sustained Decreases in Depression and Anxiety in Patients With Life-Threatening Cancer: A Randomized Double-Blind Trial, 30 J. of Psychopharmacology 1181, 1195 (2016) (single dose of psilocybin produced large and significant decreases in depression, anxiety or mood disturbance, and increases in measures of quality of life, life meaning, death acceptance, and optimism in patients with a life-threatening cancer diagnosis; effects sustained at 6 months); Matthew W. Johnson & Roland R. Griffiths, Potential Therapeutic Effects of Psilocybin, 30 Neurotherapeutics 734, 734 (2017); Stephen Ross, Therapeutic Use of Classic Psychedelics to Treat Cancer-Related Psychiatric Distress, 30 Int’l Rev. Psychiatry 317 (2018) (review of clinical trials from 1960–2018 researching therapeutic use of psychedelic treatment in patients with serious or terminal illnesses and related psychiatric illness; psychedelic-assisted treatment produces rapid, robust, and sustained improvements in cancer-related psychological and existential distress.). See also Tara C. Malone et al., Individual Experiences in Four Cancer Patients Following Psilocybin-Assisted Psychotherapy, Frontiers in Pharmacology (Apr. 3, 2018), https://www.frontiersin.org/articles/10.3389/fphar.2018.00256/full (anxiety, depression, and other existential distress relieved with psilocybin treatment;benefits were sustained throughout follow-up). See generally Lauren Slater, How Psychedelic Drugs Can Help Patients Face Death, N.Y. Times (Apr. 20, 2012), https://www.nytimes.com/2012/04/22/magazine/how-psychedelic-drugs-can-help-patients-face-death.html (“ administering psilocybin to terminally ill subjects could be done safely while reducing the subjects’ anxiety and depression about their impending deaths.”).
[2] See, e.g., Harvey Max Chochinov, Psychiatry and Terminal Illness, 45 Can. J. Psychiatry 143, 146–48 (2000); see also Wendy G. Lichtenthal et al., Do Rates of Mental Disorders and Existential Distress Among Advanced Stage Cancer Patients Increase as Death Approaches?, 18 Psychooncology 50, 54 (2009); Alex J. Mitchell et al., Prevalence of Depression, Anxiety, and Adjustment Disorder in Oncological, Haematological, and Palliative-Care Settings: A Meta-Analysis of 94 Interview-Based Studies, 12 Lancet Oncology 160, 167 tbl. 2 (2011).
[3] Research shows that 18% of terminally ill cancer patients experience moderate anxiety, while 12% suffer severe anxiety. Elissa Kolva et al., Anxiety in Terminally Ill Cancer Patients, 42 J. Pain & Symptom Mgmt. 691 (2011)).
[4] M. Pinquart et al, Depression and Cancer Mortality, Psychol. Med. 2010 Nov.;40(11) :1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20. PMID: 20085667; PMCID: PMC2935927.
[5] Kolva, et al., supra note 3, at 692.
[6] U.S. Drug Enf’t Admin., Controlled Substances (2020), https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf (listing controlled substances in alphabetical order, per authority as codified in the Controlled Substances Act, 21 U.S.C. § 811).
[7] Oregon Initiative Petition 109 (2020), https://oregonvotes.org/irr/2020/034text.pdf.
[8] Ira Byock, The Case Against Physician-Assisted Suicide and Euthanasia, in The Oxford Handbook of Ethics at the End of Life 364, 379 (Stuart J. Youngner & Robert M. Arnold eds., 2014); see also Ira Byock, Experiences of Hallucinogen Treatment, 27 The Psychologist 676, 678 (2014) (“[P]articipants report not mere alleviated anxiety or depression, but also an enduring sense of well-being.”).
[9] Ira Byock, Taking Psychedelics Seriously, 21 J. Palliative Med. 417, 419 (2018).
[10] End of Life Washington, “Policy Statement and Review: Psilocybin Therapy for Emotional Suffering Caused by Terminal Illness.” https://endoflifewa.org/news/policy-statement-and-review-psilocybin-therapy-for-emotional-suffering-caused-by-terminal-illness/
[11] For patients with pain and other distressing physical symptoms that are resistant to treatment, the intervention known as “palliative sedation” has become accepted in both law and medicine. This treatment involves the administration of medication to eliminate consciousness, so the patient has no awareness of suffering, and food and fluid are withheld until death arrives. The right of a patient to elect palliative sedation was recognized by the Supreme Court of the United States in the companion Quill and Glucksberg cases decided in 1997. See Washington v. Glucksberg, 521 U.S. 702 (1997); Vacco v. Quill, 521 U.S. 793 (1997); see also Robert A. Burt, The Supreme Court Speaks: Not Assisted Suicide but a Constitutional Right to Palliative Care, 337 New Eng. J. Med. 1234, 1234 (1997). Extensive medical literature discusses this intervention. See Susan R. Bruce et al., Palliative Sedation in End-of-Life Care, 8 J. Hospice & Palliative Nursing 320 (2006); Nathan I. Cherny & Russell K. Portenoy, Sedation in the Management of Refractory Symptoms: Guidelines for Evaluation and Treatment, 10 J. Palliative Care 31 (1994); Alexander De Graeff & Mervyn Dean, Palliative Sedation Therapy in the Last Weeks of Life: A Literature Review and Recommendations for Standards, 10 J. Palliative Med. 67 (2007); Eric L. Krakauer et al., Sedation for Intractable Distress of a Dying Patient: Acute Palliative Care and the Principle of Double Effect, 5 Oncologist 53 (2000); Paul Rousseau, Palliative Sedation in the Management of Refractory Symptoms, 2 J. Supportive Oncology 181, 185 (2004); O.S. Rosengarten et al., Palliative Sedation at Home, 25 J. Palliative Care 5, 5–11 (2009); Nathan I. Cherny, Sedation for the Care of Patients with Advanced Cancer, 3 Nat. Clinical Pract. Oncology 492 (2006). Much of this literature reflects a sharp divide between use of palliative sedation intervention for physical symptoms (which is supported), and non-physical suffering, the use of which is not allowed. See e.g., The Problem of Psychological Suffering, Stanford Sch. of Med., https://palliative.stanford.edu/palliative-sedation/the-problem-of-psychological-suffering/ (last visited Oct. 10, 2020) (“Palliative sedation for psychological or existential suffering is ethically and morally more problematic than is sedation for physical suffering.”).
[12] Oregon has a relatively large population of physicians who include aid in dying in their medical practice. In 2019, 112 physicians wrote 290 prescriptions (1–33 prescriptions per physician). Or. Health Auth., Oregon Death With Dignity Act: 2019 Data Summary 7 (2020). The number of attending physicians has increased since 1998; it has been relatively stable for the past five years. Id.
[13] AID is permitted by statute in Oregon, Washington, Vermont, California, Colorado, Hawaii, Maine, New Jersey, and the District of Columbia; additionally, it is permitted via a state supreme court decision in Montana. See Death with Dignity Acts, Death with Dignity, https://www.deathwithdignity.org/learn/death-with-dignity-acts/ (last visited Oct. 10, 2020).
[14] Opponents of AID have argued that since some dying patients can access medication to facilitate a peaceful death, access to psychedelics for palliative care should be allowed. For example, one well known end of life care clinician has written: “[I]n (various jurisdictions), a physician can legally write a prescription for lethal medications for a terminally ill person but cannot prescribe medications or make a referral for pharmaco-assisted psychotherapy that might alleviate the distress that is making the person want to end his or her life. . . . [R]elaxing the prevailing legal and regulatory restrictions on such research merits a place within the policy agendas of the medical profession, particularly the specialties of psychiatry and hospice and palliative medicine.” Byock, The Case Against Physician-Assisted Suicide and Euthanasia, supra note 35 at 379.
[15] It is not known whether psychotherapy facilitated with psilocybin would alter a patient’s choice for either palliative sedation or AID; this is a question which merits investigation.
[16] See, e.g., Chemerinsky, supra note 27 (explaining the concept of cooperative federalism).
[17] In the cannabis context, the Obama administration initially threatened to “vigorously enforce” the CSA against California, which was poised to be the first state to legalize cannabis through Prop-19. See John Hoeffel, Oct. 16, 2020, Holder Vows Fight Over Prop. 19, Los Angeles Times, https://www.latimes.com/archives/la-xpm-2010-oct-16-la-me-marijuana-holder-20101016-story.html. However, after California and Colorado proceeded with legalizing the cannabis marketplace, a policy to refrain from federal enforcement was articulated in a memorandum issued by U.S. Deputy Attorney General James Cole. See Memorandum from James M. Cole, Deputy Attorney General, Office of the Deputy Attorney Gen., on Guidance Regarding Marijuana Enf’t (August 29, 2013), https://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf. This was subsequently rescinded by Attorney General Sessions during the Trump administration. See Memorandum from Jefferson B. Sessions, Attorney General, Office of the Attorney Gen., on Marijuana Enf’t (January 4, 2018), https://www.justice.gov/opa/press-release/file/1022196/download.
[18] 21 U.S.C. § 360bbb-0a; see also Right to Try, U.S. Food & Drug Admin., https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try (last visited Aug. 27, 2020). The federal RTT was enacted after a wave of state RTT enactments, which included Oregon in 2015. See H.B. 2300, 2015 Leg., 78th Sess. (Or. 2017).
[19] Such patients must be “unable to participate in a clinical trial involving the eligible investigational drug.” 21 U.S.C. § 360bbb-0a(a)(1)(B). This would be the case for Oregonians, as no clinical trials for psilocybin use are taking place in Oregon. See Psilocybin, U.S. Nat’l Library of Med., https://clinicaltrials.gov/ct2/results/map/click?map.x=229&map.y=228&term=psilocybin&mapw =1031 (last visited Oct. 10, 2020).
[20] 21 U.S.C. §360bbb-0a(a)(2)(a).
[21] See supra note 1; see also Psilocybin Investigator’s Brochure, Usona Inst. 47-48 (2020), https://www.usonainstitute.org/wp-content/uploads/2020/08/Usona_Psilocybin_IB_V3.0_08.31.2020_cc.pdf. (last visited Jan. 31, 2021).
[22] Oregon enacted its RTT act in 2015. Compliance with the particulars of the RTT—such as payment for therapy and waiver of liability—would need to be observed. One might argue that offering psilocybin therapy to terminally ill patients seeking to advance time of death via AID should evolve as a best practice.
Kathryn Tucker, special counsel, Emerge Law Group, Portland, OR, one of the nation’s leading patient rights advocates. Kathryn is Special Counsel at Emerge Law Group, where she co-chairs the Psychedelic Practice Group.
Sunil Aggarwal: M.D., Ph.D., FAAPMR, Hospice and Palliative Medicine, co-founder and co-director, AIMS Institute. Dr. Aggarwal is a hospice and palliative medicine and physical medicine and rehabilitation physician and medical geographer. His primary clinical work is as an Integrative Pain, Palliative Care, and Rehabilitation Physician in private practice at AIMS Institute (Seattle, WA) and as an on-call MultiCare Palliative Physician and Associate Medical Director of MultiCare Hospice (Tacoma, WA).
