Disentangling debate about therapeutic and recreational use of psychedelics

While the movement to liberalize psychedelics bears many parallels to that of cannabis, there are important differences that must be considered in development of regulatory policy. It is critical to avoid conflating debates about liberalization for therapeutic and recreational purposes. As with cannabis, this conflation has been driven by advocates of recreational legalization under a veneer of medicine. We thank the commentators for their thoughtful responses to our article [1]. The commentators appear to agree that the liberalization of access to psychedelics seems likely to continue apace, that carefully constructed and regulatory policy will be required, and that policy should be guided by rigorous science. The commentators raise a number of other important considerations that are worthy of further discussion. Kilmer [2] identifies several unique regulatory matters that apply to psychedelics. First, because psychedelics are used much less frequently than alcohol or tobacco, common policy tools-such as a taxes and minimum unit pricing-will be less effective in influencing their consumption. Second, the role of supervision in the use of psychedelics takes regulators into unfamiliar terrain. For example, the authorities in Oregon and Colorado have moved to allow access to psilocybin only under the supervision of a licensed facilitator. Zullino [3] contends that we have conflated debates about the regulation of psychedelic-assisted treatment with legalization of psychedelics for non-therapeutic purposes. In fact, this conflation has been driven by some advocates who have sought to achieve recreational legalization under a veneer of medicine. The risk to public health is that the limited evidence for the therapeutic benefits of psychedelics will be used to justify access under liberal regulations that will facilitate both ineffective therapies and non-therapeutic use in much the same way that ‘medical’ cannabis legalization has done [4]. A compelling body of evidence may emerge in the future to support some therapeutic uses of psychedelics; but this is by no means a forgone conclusion. Even if there is stronger evidence on the effectiveness of psychedelic-assisted treatments for mental health conditions, it may be difficult to separate the regulation of psychedelics for therapeutic and recreational purposes (e.g. it can be hard to differentiate existential anxiety over a lack of meaning in life from an anxiety disorder). Of course, if the public wants to legalize for recreational use they can; but if medical claims are being made, our job as scientists is to evaluate their strength and the risks of bias. We appreciate and agree with Bogenschutz's [5] observation that many people are already using psychedelic drugs in an effort to treat psychiatric and substance use disorders in the absence of good evidence on their safety and effectiveness. Such experimentation has been encouraged by uncritical media coverage of the putative benefits and safety of these drugs. Experience with the off-label prescribing of ketamine for a wide range of behavioral health disorders is a cautionary example of how medical practice can get ahead of the science. To avoid replicating the pitfalls of cannabis liberalization with the psychedelics, it is critical that governments clearly distinguish the debate about whether psychedelics should be legal to use recreationally from the debate about whether psychedelics have therapeutic uses in addiction. C.M.A. receives funding from the National Institute on Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, the South Carolina Opioid Recovery Fund, the South Carolina Department of Alcohol and Other Drug Abuse Services and the Blue Cross Blue Shield Foundation. W.H. has received funding in the past 3 years from the Australia Research Council and the World Health Organization. K.H. receives salary support from the United States Department of Veterans Affairs and research grants from the National Institute on Drug Abuse and the Veterans Affairs Health Services Research and Development Service. He is a non-executive director of Indivior. J.M. declares research grants from the United Kingdom National Institute for Health Research and Indivior (sponsored by King's College London) and from Beckley PsyTech (a commercially sponsored study of psychedelic-assisted for alcohol used disorder). He serves as an advisor to the Office for Health Improvement and Disparities, English Department of Health and Social Care and the National Institute on Drug Abuse's Center for Clinical Trials Network. He declares honoraria and travel support from PCM Scientific, OPEN Health and Indivior. None.