Regulating Minds: A Conceptual Typology

By Michael N. Tennison 

Image courtesy of Wikimedia Commons.

Bioethicists and neuroethicists distinguish therapy from enhancement to differentiate the clusters of ethical issues that arise based on the way a drug or device is used. Taking a stimulant to treat a diagnosed condition, such as ADHD, raises different and perhaps fewer ethical issues than taking it to perform better on a test. Using a drug or device to enhance performance—whether in the workplace, the classroom, the football field, or the battlefield—grants the user a positional advantage over one’s competitors. Positional enhancement raises issues of fairness, equality, autonomy, safety, and authenticity in ways that do not arise in therapy; accordingly, distinguishing enhancement from therapy makes sense as a heuristic to flag these ethical issues. 

These categories, however, do not capture the entire scope of the reasons for and contexts in which people use drugs or devices to modify their experiences. Consider psychedelic drugs like psilocybin and LSD that induce mystical-type experiences. Studies show that these drugs also have the potential to treat depression, anxiety, and addiction. They can even lead to positive changes in the personalities and behaviors of healthy subjects, such as increased openness and altruism, that can persist long-term without retaking the drug—effects that are neither therapeutic in the sense of treating a diagnosable condition, nor are they positional enhancements akin to taking steroids to gain a leg up on one’s athletic competition. 

Legal regimes that regulate drugs in the United States present a different dichotomy for distinguishing uses of drugs, ostensibly based on their risk/benefit ratios. In general, FDA laws and regulations authorize the therapeutic use of drugs proven to be sufficiently safe and effective, and controlled substance laws criminalize the use of drugs determined to lack medical value or that are obtained and used outside the scope of medical treatment. Unfortunately, the “War on Drugs”—the laws and policies implementing controlled substance restrictions—produces myriad side effects. These include unintuitive, unscientific, and politically-motivated drug classifications, interference with medical research, misinformation about the risks and benefits of drugs, stigmatization of non-problematic drug use, and the privileging of medical value as the only redeeming benefit an illegal drug can have, not to mention the panoply of harms imposed by criminalization. 

In a step toward developing a robust assessment of drug harms, a UK study ranked drugs based on their harm to users and others, using physical, psychological, and social criteria.  The findings, later endorsed by a panel of experts from across the EU, suggest a mismatch between the legal treatment of drugs and their comparative harms.  

Although ensuring the safety and effectiveness of drugs is an absolutely essential government function, generalizing and criminalizing non-medical use as “recreational drug use” or “drug abuse” fails to account for, and stifles, the other ways drugs can and do benefit individuals and society. Again, consider psilocybin, a drug designated in the United States as having no accepted medical value, a high potential for abuse, and no capacity to be used safely under medical supervision—a stricter legal classification than for cocaine, methamphetamine, and fentanyl. Even if conclusively proven safe and effective for medical or enhancement purposes, it would still be illegal to obtain and use psilocybin to enhance insight, catalyze personal development, and cultivate altruism and openness. Short of congressional action, there is no legal mechanism to acknowledge the scientific evidence of a scheduled drug’s safety and effectiveness for enhancement, and therefore authorize its non-medical use. 

The legal classification scheme fails, therefore, to accurately represent and respond to rapidly-accumulating, novel evidence about the actual risk/benefit ratios of certain drugs like psilocybin, while the neuroethical enhancement/therapy paradigm fails to account for the uses of drugs and devices that fall outside the boundaries of medicine and positional enhancement. I propose creating a single framework of functional categories that serves as both a descriptive typology and a normative spectrum that balances a higher level of precision and accuracy with the categorical bundling of thematic clusters of ethical issues. Ordered from the most to least ethically-justified, based on risk/benefit ratios at individual and collective levels, this framework comprises therapy, virtue enhancement, utility enhancement, and recreation enhancement. 

Therapy 

Therapy aims to restore the health and “normal” functions of individuals impaired by disease or injury. In discussions about enhancement, therapy tends to be the normative baseline against which enhancement is compared and contrasted because, over time, we have accrued a set of familiar attitudes, norms, and legal structures that drive our understanding of medical treatment. We understand that health and healthcare are prerequisites to flourishing as individuals and societies. 

Virtue Enhancement 

Image courtesy of Flickr.

Studies show that the controlled and supervised administration of psychedelics reliably induces a “peak” or “mystical” subjective experience of altered perceptions, mood, and cognition characterized by feelings of oneness, transcendence, and ineffability. Anxiety and fear are not uncommon elements, but careful management of the “set and setting” of the experience successfully protects the psychological safety of study participants. In a 2006 study, most subjects rated their psilocybin experience as “either the single most meaningful experience of his or her life or among the top five most meaningful experiences of his or her life.” Further research recently demonstrated that this may lead to sustained, positive changes in personality, worldview, or behavior that may benefit society, especially if reinforced by personal development practices such as meditation. 

I differentiate virtue enhancement from the kind of “moral enhancement” envisioned by bioethicists that would neurologically force the expression of a pro-social behavior, such as honesty, and that would only be effective so long as the individual is under the enhancement’s neurochemical influence. By contrast, studies show that psychedelic experiences may prompt a more “natural” or authentic pursuit of personal development that persists long after the drug experience itself has passed. 

Utility Enhancement 

This category refers to the use of a drug or device to enhance performance in an outcome-based endeavor. Whereas virtue enhancement is valuable in itself and in consequence for individuals and society, utility enhancement is valuable primarily in consequence. And despite enhancing performance on collectively-valued activities, such as work, academics, and sports, the overall value of utility enhancement is limited by the myriad of ethical issues raised. 

Utility enhancements are typically positional enhancements that grant leverage in zero-sum endeavors where people are competing for limited resources. For example, it is generally considered unfair for an athlete to use steroids to enhance performance in sports, because a better outcome for the enhanced individual or team automatically means a worse outcome for the opponent. Additionally, players may not have equal or affordable access to the most effective, least detectable, and safest enhancements, and many athletes may not want to risk professional or legal penalties if they are caught. Yet to remain competitive, they may feel forced to enhance themselves, thereby reducing their freedom and autonomy. 

Recreation Enhancement 

Image courtesy of Pxhere.

On one hand, recreation enhancement entails the use of a drug or device to enhance one’s experience of a recreational activity. Using a transcranial stimulation device to enhance video game performance, for example, provides some individual benefit without raising substantial ethical issues at the collective level. Studies now show that psychedelics can enhance the emotional appreciation of music, a finding that spans recreation, virtue enhancement, and even therapy—depending on the context and intent of use—and could have both individual and collective benefit. 

On the other hand, people also modify their minds with drugs and devices as a form of recreation itself. This parallels the concepts of “recreational drug use” and Robert Nozick’s “experience machine”—a critique of hedonism—entailing escapism or “tuning out” from reality. By chemically or electrically inducing a desired state, such as satisfaction or pleasure, one circumvents the natural process of effort and achievement, raising concerns about authenticity and the prospect of an unfavorable ratio between benefits and health risks. If a user seeks a change in consciousness as a short-term end goal in itself, without harnessing it to pursue other ethically-sound ends, it may provide little overall benefit to the individual or society. However, it is not necessarily harmful if not pursued to the point of interference with health or responsibilities. 

None of the above categories should be conflated with use disorders. In fact, a use disorder could result from the inappropriate pursuit of any of the above categories of substance use. According to SAMHSA, the DSM-5 defines a substance use disorder as being present when “the recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home.” Despite the prevalence of use disorders revealed by the nation-wide opioid crisis in the United States, it is important to remember that 80-90% of users of illegal drugs do not have a drug problem, according to Dr. Carl Hart, neuroscientist and chair of psychology at Columbia University. Similarly, data from a 2017 report of the UN Office on Drugs and Crime show that globally, almost 90% of people who use internationally-controlled drugs do not have substance use disorders. Indeed, by taking seriously the studies that demonstrate the non-problematic and even beneficial uses of drugs legally-classified as necessarily harmful, we are better equipped to identify risk factors of addiction and problematic use. 

Laws should encourage activities that benefit individuals and society and discourage those that do not. Creating a unified and coherent approach to understanding how and why people manipulate their consciousness with drugs and devices is a first step toward systematically incorporating intuitive, evidence-based risk/benefit analyses into our ethical, legal, social, and policy discussions. This facilitates the accurate identification and assessment of the unique clusters of ethical issues associated with different purposes and outcomes of drug and device use. Such assessments could be translated into laws and regulations that promote the discovery and application of beneficial manipulations of consciousness, even if non-medical, while implementing structures and processes to reduce their risk of harm. The next steps entail sorting out how drugs and devices could be approved and administered for different kinds of enhancement, including the requisite thresholds of scientific proof of safety and effectiveness and the proper context of use to minimize risks—whether inpatient, over the counter, by prescription, or after demonstrating sufficient knowledge and competence, as with obtaining a driver’s license. A model like the one proposed above can enhance our neuroethical analyses and help us to overcome our dangerous experimentation with harmful drug laws and policies.

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Michael N. Tennison is a Senior Law & Policy Analyst at the University of Maryland Center for Health and Homeland Security. His research interests focus on the ethical, legal, social, and scientific issues associated with drug policy. The opinions expressed are the author's own and do not represent the view of the Center for Health and Homeland Security or the University of Maryland. Portions of this post are adapted from the author’s poster presentation at the 2017 Annual Meeting of the International Neuroethics Society. 

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Tennison, M. (2018). Regulating Minds: A Conceptual Typology. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2018/05/regulating-minds-conceptual-typology.html

The Army's on Ecstasy: Marching toward an ethical drug policy

Post-traumatic stress disorder (PTSD) among American soldiers returning from Iraq and Afghanistan has reached epidemic proportions, affecting between 75,000 to 225,000 veterans. In fact, suicide is now the leading cause of death in the army, with more soldiers dying by suicide than in combat. Frustratingly, existing treatments for PTSD are limited and ineffective for between 25-50% of patients. Last year a clinical trial using MDMA (i.e. Ecstasy) in conjunction with psychotherapy was shown to ameliorate PTSD symptoms far more effectively than any other known treatment. Despite these promising results, it could be ten years or more before MDMA is approved for use in treating PTSD, and even then clinicians will face additional hurdles until our nation’s drug policy is seriously overhauled. Given the public health imperative for effective PTSD treatment, it’s high time to rethink our stance toward illegal drugs and create an ethical drug policy that paves the way for expedient psychedelics research while providing honest education, harm reduction measures, and on-demand treatment for drug addiction.



PTSD is a chronic, debilitating mental illness. People with PTSD are hyperaroused, repeatedly re-experience their trauma in the form of nightmares, panic attacks, and flashbacks, and often suffer from comorbid depression and drug abuse. The army's own research illustrates that trauma is widespread and long-lasting: around 25% of Vietnam veterans remain symptomatic, even decades after the end of their service. The army is fully aware of this growing issue, and has taken many steps over the years to address it, including the formation of the National Center for PTSD within the US Department of Veterans Affairs, which has emerged as the world’s leading research and educational center on PTSD. The Obama administration has also increased funding for mental health services at the VA by 39% since 2009. Despite these and other efforts, the statistics are alarming: about 18 veterans take their lives each day.



PTSD treatment typically involves pharmacotherapy, psychotherapy, or some combination of both. To date, the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine are the only two FDA-approved drugs to treat PTSD, although others are prescribed off-label. Meta-analyses, which pool data from dozens of randomized clinical trials (RCTs) to try to assess drug efficacy, have found SSRIs to be slightly more effective than placebo, with about 50% of RCTs finding medication to be more effective than placebo in reducing PTSD symptoms. However, SSRIs take several weeks to begin working, often have undesirable side-effects, and many patients fail to respond at all. Psychotherapeutic approaches for PTSD include cognitive behavioral therapy (CBT) and psychodynamic psychotherapy, which are often effective, although attrition rates are high and many never respond. Clinicians and researchers alike recognize the need for more treatments, and the army is scrambling to find them, even exploring mindfulness-based therapies, such as loving-kindness meditation.

MDMA-assisted psychotherapy offers hope for those suffering from PTSD, but the US' fear-based approach to drug policy and education has delayed its development into an approved medicine. (credit: www.maps.org/)

The trick to successful PTSD psychotherapy is to hit the “window of tolerance,” wherein the patient is neither over- nor under-aroused while revisiting his past trauma. Within this sweet spot, the patient can work through difficult emotions without overwhelming anxiety (hyperarousal) or numbing detachment (underarousal). Finding this zone is tricky, requiring the establishment of a trusting patient-therapist relationship, a degree of introspective awareness by the patient, and massive amounts of courage. This may sound simple, but many veterans have spent months, years, or even decades in silence, repressing and suffering through their traumatic memories and emotions. Additionally, therapy within the optimal arousal zone must be ongoing; it’s not a one-shot deal. If therapists or scientists could devise a means by which patients with PTSD could widen, maintain, and more quickly establish this openness, therapy sessions could deliver results more quickly and effectively. And this is exactly where MDMA comes in.

MDMA, known by its street name, Ecstasy, is a psychoactive drug that produces feelings of euphoria, a sense of intimacy with others, and diminished anxiety. It belongs to a class of drugs known as “empathogens,” or “entactogens,” implying that its effects (typically 4-6 hours in duration) increase one’s ability to empathize or feel. MDMA was first synthesized a hundred years ago, but was popularized by the organic chemist, Alexander Shulgin, in the 1970’s. Shulgin himself experimented with the drug and shared it with colleagues and friends, some of whom began using it in psychotherapy sessions. Among underground psychotherapists, MDMA developed a reputation for enhancing communication during clinical sessions, reducing patients’ psychological defenses, and increasing capacity for therapeutic introspection. By the early 1980’s, an estimated 500,000 doses of underground MDMA had been consumed under the code name "Adam," with the media and drug enforcement agencies taking no notice of that use, as sessions were conducted in private settings and didn't produce problems (see Rosenbaum & Doblin for an historical account).



But this soon changed, as MDMA spilled out into the club scene and the US Drug Enforcement Agency (DEA) took notice. In response to impending drug legislation, the medical community presented their research findings to DEA Administrative Judge Francis L. Young, who recommended that MDMA be placed under Schedule III, meaning it had medicinal value but may lead to dependency or abuse (by comparison, Ritalin is a Schedule II substance due to its medicinal value but higher potential for abuse). But in the mid-80’s, Ronald Reagan’s “War on Drugs” was raging, and the DEA placed MDMA under Schedule I, the most restrictive status for a controlled substance. From then until today, federal law states that MDMA has “no currently accepted medical use in treatment” and “a lack of accepted safety for use…under medical supervision.”



This ruling proved devastating for research into the potential therapeutic benefit of MDMA. In spite of the legislation, researchers persisted in their attempts to study the drug’s cognitive and behavioral effects and to prove that it was safe for responsible use by the medical community. But roadblocks to the timely progress of their research were insurmountable. Researchers around the world were pressing for more studies on the potential therapeutic benefits of MDMA in treating psychiatric disorders, such as pain, anxiety, depression, and most importantly, PTSD. Between 1986 and 1988, five different applications for permission to conduct double-blind, controlled studies with MDMA in human subjects were submitted to the US Food and Drug Administration (FDA). All were summarily rejected. Scientists quickly became hip to the fact that securing government approval, obtaining drug licenses, and gaining institutional review board (IRB) support for human studies were both untimely and cost-prohibitive, and so human MDMA research ground to a standstill. Psychiatrists, with their careers and licenses at stake, abandoned their clinical use of the drug. And with that, the hope that MDMA could some day ameliorate the suffering of the many PTSD-afflicted men and women returning home from armed combat disappeared.



Fast-forward to 2001. After sixteen years of sustained effort, Dr. Rick Doblin, founder and director of the Multidisciplinary Association for Psychedelics Research (MAPS), a non-profit research and educational organization that supports scientific research into therapeutic uses for psychedelics, finally obtained FDA approval for an MDMA-assisted psychotherapy study. Nevertheless, it took Dr. Doblin and other investigators three more years of battling with the DEA and Independent Review Boards (IRBs) before the first experimental session with MDMA-assisted psychotherapy was carried out in a PTSD patient (for a brief history, see Check 2004). The study was finally completed in 2008 and its overwhelmingly promising results published in 2010 (see below). That’s a full nine years from FDA approval to results and publication. (Comprehensive information about MDMA-assisted psychotherapy research can be found here.)

The first Phase II clinical trial using MDMA-assisted psychotherapy to treat PTSD finds that 83% of subjects receiving MDMA no longer met PTSD-criteria after two months, compared to only 25% in the placebo group. (Mithoefer et al., 2011. J Psychopharmacol. 25(4):439-52)

 I had the opportunity to speak with Dr. Doblin about why MDMA/PTSD research over the years has been so painfully slow. According to Dr. Doblin, there remains “a delay that takes place with MDMA research because of drug policy.” Doblin explained that as a Schedule I controlled substance, MDMA could take another 10 years before it’s rolled out for use to treat PTSD. He believes that this is largely due to the unscientific, fear-based approach that the National Institute on Drug Abuse (NIDA), DEA, and the Office of National Drug Control Policy (ONDCP) have taken in their drug education and policymaking, and the reticence of scientific researchers to advocate on behalf of a sensible, empirically-driven approach toward drug policy. The government, especially the DEA and NIDA, continues to balk at research that poses, as Doblin puts it, “a threat to NIDA’s educational campaign.”



Doblin believes that this educational campaign is based on the notion that “drug use goes up when the perception of risk goes down.” Consequently, drug education programs exaggerate the risk of any and all illicit drugs, even when the science clearly dictates otherwise. Cannabis is an obvious example. Despite its medicinal applications for patients with cancer, chronic pain, and insomnia, the government has opted to “sacrifice those patients and those benefits because [they] want to tell a story to people” that cannabis is exceedingly dangerous. And the same sacrifice is now being made with MDMA for PTSD. The government’s basic argument is that they “can’t have unfettered scientific explanations because if it proves that some of these drugs are beneficial in some way, that will send the ‘wrong’ message to people. Therefore, they have to block science because there may be some inconvenient findings. Drug abuse prevention should instead be based on honest information. If you can start with that, everything is different, and you’re not scared of research that may show potential benefits.”



The government’s current scheme raises a number of ethical concerns. Obstructing scientific progress or misrepresenting scientific evidence to fit a political agenda harms scientists, patients, and society at large. The mission of mental health scientists in the US, as stated by the National Institute of Mental Health (NIMH) is to “transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.” However, in the case of developing novel therapies using recreational drugs like MDMA, drug policy prevents scientists from paving that road. This is simply unethical. As Doblin clearly stated, “when scientists see that politics is blocking their research, they have an obligation to point that out.” Scientists should challenge such practices by speaking out in public forums, participating in educational programs that promulgate evidence-based information, and supporting political organizations that advocate drug policy reform, such as the Drug Policy Alliance. Patients, in this case trauma survivors, must also make their voices heard by massively mobilizing against bureaucratic maneuvering that impedes their fair, timely access to effective treatments. For veterans with PTSD, their lives literally depend on it. Those who don’t suffer from PTSD or conduct research using controlled substances must examine the value they place on scientific inquiry, even when it challenges their preconceived social, political, or religious notions. At play here is also the broader issue of cognitive liberty, whether an individual is free to alter the state of his or her consciousness using any method available. This includes stimulants like Ritalin for cognitive enhancement in healthy adults, psychedelics like MDMA for informal psychotherapy, and LSD and psilocybin for spiritual visionaries. Do we really want to live in a society where the limits of human curiosity, creativity, and well-being are restricted? Hopefully, conversations about how best to expand and protect these freedoms while minimizing harm will permeate public dialogue.



In summary, this country is slowly emerging from a dark age in drug policy. Government regulators are just beginning to take a more reasoned approach toward research into stigmatized illegal drugs like MDMA, but a long road lies ahead. Even though the present administration has eschewed the term, the “War on Drugs,” and stated that “drug policies must be rooted in science,” its Director of the Office of National Drug Control Policy, Gil Kerlikowske, still believes that cannabis is “a dangerous drug,” and that the “Just Say No” campaign is one of the “major successes” of drug education. Progress is slow, indeed, and will require a grassroots, coordinated effort to effect significant change. As our service men and women continue to suffer, and the low-hanging fruit of MDMA-assisted psychotherapy remains out of their reach for at least a decade more, it is now our duty to serve them and advocate for a science-based drug policy that clears the path for psychedelics in treating mental illness.





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Kohn, J. (2012). The Army’s on Ecstasy: Marching Toward an Ethical Drug Policy. The Neuroethics Blog. Retrieved on
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