Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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America divided concept, american flag on cracked background.

Can Psychedelics Help Save America?

By Shelby Hartman

Amid a fractured political landscape, an unprecedented pandemic, and a reckoning with the country’s racist past, psychedelics may offer some hope for healing in the United States. In recent decades, a renaissance of psychedelic drug research has grown at prominent institutions like Johns Hopkins, New York University, and Imperial College London, among others.

Psilocybin, the psychoactive component in psychedelic mushrooms, and MDMA, sometimes confused with its adulterated version, ecstasy, have both been given breakthrough therapy status by the Food and Drug Administration (FDA), because they’ve shown so much promise for treating conditions for which we currently have few effective options. Psilocybin for treatment-resistant depression and MDMA for post-traumatic disorder are projected to be legal within the next five years as drugs that will be administered under the supervision of trained therapists.

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Police cars.

The False Promise of City-Wide Psilocybin Decriminalization

By Kathryn Lucido

While city-wide decriminalization of psilocybin is a positive step toward decreasing the impact of the war on drugs, it also creates a false sense of security and progress.

Citing new research that illustrates the therapeutic promise of the drug, several U.S. cities have decriminalized psilocybin, a psychedelic compound that occurs naturally in some fungi. Though these cities have pledged not to spend resources prosecuting people for psilocybin possession, and, in some cases, limited distribution, the substance remains illegal at the federal, state, and city levels.

Psilocybin remains a Schedule I drug under the Controlled Substances Act. This classification means that — at least according to Congress and the Drug Enforcement Administration — psilocybin is a dangerous drug with no currently accepted medical uses and a high risk for abuse.

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two watercolor silhouettes.

Neurodiversity and Psychedelics Decriminalization

By Dustin Marlan

Following over fifty years of the racist and corrupt war on drugs, drug decriminalization is now a social justice issue. As I explore in Beyond Cannabis: Psychedelic Decriminalization and Social Justice, the decriminalization of psychedelic drugs, in particular, is a matter of diversity, equity, and inclusion.

Psychedelics have long been prohibited under Schedule I of the federal Controlled Substances Act. However, after successful efforts in Denver, Oakland, Santa Cruz, and Ann Arbor, there are now attempts underway to decriminalize psilocybin mushrooms and other natural psychedelics in over 100 cities across the country, including Washington, D.C., which will vote on Initiative 81 in November 2020.

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man lying on couch.

Psychedelics and America: A Digital Symposium

By Mason Marks

In 2020, the psychedelics research and policy reform renaissance is in full swing. Prohibited by federal law since the 1970s, psychedelic substances can alter how people see themselves, the world, and those around them. Clinical trials suggest they may help people overcome ingrained thought patterns associated with depression, anxiety, and addiction.

Acknowledging their spiritual and therapeutic potential, universities have established new psychedelics research programs. The Food and Drug Administration (FDA) has deemed them breakthrough therapies for depression and post-traumatic stress disorder. This designation means they could be significant improvements over traditional treatments such as selective serotonin reuptake inhibitors (SSRIs). Accordingly, the FDA has put some psychedelics on an accelerated course toward approval. Eventually, they could help millions who have not benefitted from existing therapies.

However, despite their breakthrough status, psychedelics will not become FDA approved for several years. Meanwhile, the COVID-19 pandemic is making the country’s mental health crisis worse. According to the Centers for Disease Control and Prevention, rates of depression, anxiety, substance use, and suicidal thoughts have risen in the past nine months.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back

By Mason Marks

Amid rising rates of depression, suicide, and substance use disorders, drug makers have scaled back investment in mental health research. Psychedelics may fill the growing need for innovative psychiatric drugs, but federal prohibition prevents people from accessing their benefits. Nevertheless, some cities, dissatisfied with the U.S. war on drugs, are decriminalizing psychedelics.

In 2019, Denver became the first U.S. city to decriminalize mushrooms containing psilocybin, a psychedelic the FDA considers a breakthrough therapy for major depressive disorder (MDD) and treatment-resistant depression.

In a historic vote, Denver residents approved Ordinance 301, which made prosecuting adults who possess psilocybin-containing mushrooms for personal use the city’s “lowest law enforcement priority.” Since then, in Oakland and Santa Cruz, California, voters approved their own decriminalization measures.

As a Schedule I controlled substance, psilocybin remains illegal under federal law, and despite ongoing clinical trials, it is unlikely to become FDA approved for several years. Social distancing requirements due to COVID-19 are disrupting medical research causing further delays. But as the November election approaches, other U.S. cities prepare to vote on psychedelics.

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Tort Reform in Oregon: Constitutional, After All?

By Alex Stein

Three years ago, Oregon’s Supreme Court voided the state’s $500,000 cap on noneconomic damages for medical malpractice for violating the constitutional guarantee that “In all civil cases the right of Trial by Jury shall remain inviolate” (Or. Const., Art. I, § 17, as interpreted in Lakin v. Senco Products, Inc., 987 P.2d 463, modified, 987 P.2d 476 (Or. 1999)). Klutschkowski v. Oregon Medical Group, 311 P.3d 461 (Or. 2013). This cap also clashed with “every man’s” right to “remedy by due course of law for injury done him in his person, property, or reputation” (Or. Const., Art. I, § 10, as interpreted in Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and in Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008)). The Court reasoned that a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857, when Oregon adopted its constitution, cannot be abolished or abridged by statute or common law. For my discussion of the Klutschowski decision, see here. For my discussion of a similar entrenchment principle adopted by the Utah Supreme Court in Smith v. United States, 356 P.3d 1249 (Utah 2015), see here.

The Oregon Supreme Court has now changed this course in a long precedential decision, Horton v. Oregon Health and Science University, — P.3d —- 359 Or. 168 (Or. 2016). Read More

Medical Malpractice: The New Wave of Constitutional Attacks on Damage Caps

By Alex Stein

About forty-five years ago, tort reforms took off and states have started capping compensation awards for victims of medical malpractice. The plaintiffs bar countered this initiative by raising different constitutional challenges against caps. Those challenges alluded to equal protection, due process, separation of powers, and the general right to a jury trial. Some state courts have rejected those challenges, while other courts have struck the caps down for being unconstitutional. For discussion and the list of representative cases, see Alex Stein, Toward a Theory of Medical Malpractice, 97 Iowa L. Rev. 1201, 1253-54 (2012).

Courts’ decisions in favor and against the caps juxtaposed the victim’s entitlement to remedy against society’s interest in reducing doctors’ compensation burden and cost of liability insurance. Courts that gave precedence to the latter interest did so in the hopes to contain the cost of medical care for patients. The “trickle down” theory underlying these hopes has been questioned on empirical and doctrinal grounds. See Tom Baker, The Medical Malpractice Myth 1-21 (2005) (demonstrating that claims linking the cost of medical care to medical-malpractice liability are empirically unfounded and calling them an “urban legend”) and Stein, id. at 1247-56 (showing that, as a doctrinal matter, doctors can be found responsible for patients’ injuries only in extreme cases and that a rational physician should care more about being identified and reported to the federal databank as a malpractitioner than about how much she will pay if found liable). The Florida Supreme Court has rejected that theory in a recent decision, McCall v. United States, 134 So.3d 894 (Fla. 2014), that relied (inter alia) on Tom Baker’s work. For my discussion of this landmark decision, see here.

For obvious reasons, plaintiffs’ attorneys are loath to depend on such tradeoffs and prefer to base their claims on constitutional rights that are not subject to balancing.  Read More

Oregon’s Unfulfilled Tort Reform

By Alex Stein

Oregon has a statute capping noneconomic damages recoverable in medical malpractice suits at $500,000.

The Oregon Supreme Court decided that this cap is unconstitutional insofar as it clashes with a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857 when Oregon adopted its constitution. Specifically, it ruled that Article I, sections 10 and 17, of the Oregon Constitution entrench this right and deny the legislature the power to curtail it: see Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008). This ruling separated the constitutionally protected pre-1857 causes of action, which the statutory cap cannot curtail, from the constitutionally unprotected causes of action that came into existence after 1857 and that can consequently be capped.

Consequently, in order to reduce a jury’s award of noneconomic damages to $500,000, the defendant must show that the plaintiff’s complaint was not actionable before 1857. To adjudicate such claims, courts must carry out an historical investigation into Oregon’s medical malpractice law.

The Court’s most recent decision on that issue, Klutschkowski v. Oregon Medical Group, — P.3d —-, 2013 WL 5377913 (Or. 2013), made this task easy to perform. Read More