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Psychedelic drugs should be legally reclassified so that researchers can investigate their therapeutic potential

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Trials of physiologically safe and non-addictive drugs such as LSD are almost impossible, writes James J H Rucker , calling on the authorities to downgrade their unnecessarily restrictive class A, schedule 1 classification Psychedelic drugs, especially lysergic acid diethylamide (LSD) and psilocybin, which is found in the Psilocybe genus of “magic” mushrooms that grow throughout the United Kingdom, were extensively used and researched in clinical psychiatry before their prohibition in 1967. Hundreds of papers, involving tens of thousands of patients, presented evidence for their use as psychotherapeutic catalysts of mentally beneficial change in many psychiatric disorders, problems of personality development, recidivistic behaviour, and existential anxiety.1 This research abruptly ended after 1967, when psychedelics were legally classified as schedule 1 drugs under the UK Misuse of Drugs Regulations and as class A drugs under the UK Misuse of Drugs Act 1971. Schedule 1 in the UK broadly mirrors schedule I of the 1971 United Nations Convention on Psychotropic Substances, adoption of which is a requirement of UN membership.2 This classification denoted psychedelic drugs as having no accepted medical use and the greatest potential for harm, despite the existence of research evidence to the contrary. Indeed, in 1992 John Ehrlichman, …
PERSONAL VIEW
Psychedelic drugs should be legally reclassified so
that researchers can investigate their therapeutic
potential
Trials of physiologically safe and non-addictive drugs such as LSD are almost impossible, writes
James J H Rucker, calling on the authorities to downgrade their unnecessarily restrictive class A,
schedule 1 classification
James J H Rucker specialist registrar in adult psychiatry and honorary clinical lecturer, MRC Social,
Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience,
King’s College, London, SE5 8AF
Psychedelic drugs, especially lysergic acid diethylamide (LSD)
and psilocybin, which is found in the Psilocybe genus of “magic”
mushrooms that grow throughout the United Kingdom, were
extensively used and researched in clinical psychiatry before
their prohibition in 1967. Hundreds of papers, involving tens
of thousands of patients, presented evidence for their use as
psychotherapeutic catalysts of mentally beneficial change in
many psychiatric disorders, problems of personality
development, recidivistic behaviour, and existential anxiety.1
This research abruptly ended after 1967, when psychedelics
were legally classified as schedule 1 drugs under the UK Misuse
of Drugs Regulations and as class A drugs under the UK Misuse
of Drugs Act 1971. Schedule 1 in the UK broadly mirrors
schedule I of the 1971 United Nations Convention on
Psychotropic Substances, adoption of which is a requirement
of UN membership.2This classification denoted psychedelic
drugs as having no accepted medical use and the greatest
potential for harm, despite the existence of research evidence
to the contrary.
Indeed, in 1992 John Ehrlichman, former assistant to Richard
Nixon—the US president who intensified the “war on drugs”
in the 1970s—notoriously admitted that the administration had
lied about the harmful effects of drugs and had manipulated
media coverage of them for political advantage.3Nearly 50 years
later psychedelic drugs remain more legally restricted than
heroin and cocaine, which are schedule 2, class A in the UK.
But no evidence shows that psychedelic drugs are habit forming;
little evidence shows that they are harmful in controlled settings;
and much historical evidence has shown that they could have
use in common psychiatric disorders. A growing number of
organisations, most recently in Norway, are questioning the
need for such draconian restrictions.4
Where’s the harm?
Psychedelic drugs do not induce dependence.5A 1984 review
of adverse reactions to psychedelics found little evidence of
harm in controlled settings.6Furthermore, in 2010, an analysis
of harms caused to recreational users and to society by a range
of psychotropic substances ranked LSD and psilocybin among
the safest of all those studied.7The therapeutic index (toxic dose
as a ratio of standard dose) for LSD and psilocybin is about
1000; for cocaine it is 15, for heroin it is 6, and for alcohol it is
10.8The belief that psychedelics induce homicidal or suicidal
behaviour was inculcated by the politically driven and media
led condemnation of LSD in the 1960s.9
In a population study of 130 152 respondents to the US National
Survey on Drug Use and Health (NSDUH) from 2001 to 2004,
a history of reported psychedelic use was associated with lower
reported levels of serious psychological distress, the need for
mental health treatment, and psychiatric medicine.10 Researchers
found no association with psychosis. Using data from the
2008-12 NSDUH (n=191 382) Hendricks et al found that ever
having used psychedelics was associated with a significantly
reduced risk of suicide.11 These results have been broadly
replicated in another sample of 135 095 randomly selected US
adults.12
Evidence for medical use
Many of the clinical trials of psychedelics published in the 1950s
and ’60s, before prohibition, fell short of modern standards;
however, several good quality, controlled trials were performed.
Using data from six such trials in alcoholism, a recent
meta-analysis that compared treatment with LSD against
controls in 536 people found that LSD treatment was favoured
james.rucker@kcl.ac.uk
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BMJ 2015;350:h2902 doi: 10.1136/bmj.h2902 (Published 26 May 2015) Page 1 of 2
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VIEWS & REVIEWS
in terms of objectively measured improvements in alcohol
misuse, with an odds ratio of 1.96 (95% confidence interval
1.36 to 2.84).13 Recent pilot studies performed outside the UK
have shown clinical efficacy in anxiety associated with advanced
cancer,14 obsessive compulsive disorder,15 tobacco addiction,16
alcohol addiction,17 and cluster headaches.18
However, larger clinical studies are almost impossible
throughout the Western world because of the practical, financial,
and bureaucratic obstacles imposed by schedule 1 classification
or its equivalent.19 For example, because of the burden of
compliance with the UN’s schedule I, only one manufacturer
in the world produces psilocybin at sufficient quality, quoting
our group a prohibitive £100 000 for 1 g (50 doses).
In the UK, to hold a schedule 1 drug, institutions require a
licence costing about £5000. Only four hospitals currently hold
such licences, which come with regular police inspections and
onerous rules on storage and transport. Prescribers of a schedule
1 substance also must hold a licence, which costs £3000.
These restrictions, and the accompanying bureaucracy, mean
that the cost of clinical research using psychedelics is 5-10 times
that of research into less restricted (but more harmful) drugs
such as heroin—with no prospect that the benefits can be
translated into wider medical practice. The self reinforcing cycle
of stigma generated by schedule I classification means that
almost all grant funders are uncomfortable funding research
into psychedelics, and similar problems are encountered with
ethics committees.
Legal prohibition of some psychotropic substances continues
to be a condition of UN membership, stigmatising a facet of
behaviour and arguably causing more harm than it prevents.20
The UN schedule I creates its own circular argument for
psychedelics to remain stringently restricted, even though the
original reasons for classifying them as such were largely
fallacious.
Because psychedelics are not harmful in relation to other
controlled substances and are not habit forming, and because
evidence suggests medical use, we call on the UK Advisory
Council on the Misuse of Drugs and the 2016 UN General
Assembly Special Session on Drugs to recommend that
psychedelics be reclassified as schedule 2 compounds to enable
a comprehensive, evidence based assessment of their therapeutic
potential.
Competing interests: I have read and understood the BMJ policy on
declaration of interests and have no relevant interests to declare.
I thank Robin L Carhart-Harris and David J Nutt, Centre for
Neuropsychopharmacology, Division of Brain Sciences, Imperial College
London, W12 0NN.
Provenance and peer review: Not commissioned; not externally peer
reviewed.
1 Grinspoon L, Bakalar J. The psychedelic drug therapies. Curr Psychiatr Ther
1981;20:275-83.
2 United Nations. Convention on psychotropic substances, 1971. www.unodc.org/pdf/
convention_1971_en.pdf.
3 Baum D. Truth, lies, and audiotape. In: Smith L, ed. The moment: wild, poignant, life
changing stories from 125 writers and artists. Harper Perennial, 2012.
4 Higgins A. Odd push in drug averse Norway: LSD is OK. nytimes.com 4 May 2015. http:
//bit.ly/1FntGeK.
5 Brunton L, Chabner B, Knollman B. The pharmacological basis of therapeutics. 12th ed.
McGraw Hill Professional, 2011.
6 Strassman RJ. Adverse reactions to psychedelic drugs: a review of the literature. J Nerv
Ment Dis 1984;172:577-95.
7 Nutt DJ, King LA, Phillips LD. Drug harms in the UK: a multicriteria decision analysis.
Lancet 2010;376:1558-65.
8 Gable RS. Comparison of acute lethal toxicity of commonly abused psychoactive
substances. Addiction 2004;99:686-96.
9Grinspoon L, Bakalar J. Psychedelic drugs reconsidered. 1st ed. Lindesmith Center, 1997.
10 Krebs TS, Johansen PØ. Psychedelics and mental health: a population study. PLoS One
2013;8:e63972.
11 Hendricks PS, Thorne CB, Clark CB, et al. Classic psychedelic use is associated with
reduced psychological distress and suicidality in the United States adult population. J
Psychopharmacol 2015;29:280-8.
12 Johansen PØ, Krebs TS. Psychedelics not linked to mental health problems or suicidal
behavior: a population study. J Psychopharmacol 2015;29:270-9.
13 Krebs TS, Johansen PØ. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis
of randomized controlled trials. J Psychopharmacol 2012;26:994-1002.
14 Grob CS, Danforth AL, Chopra GS, et al. Pilot study of psilocybin treatment for anxiety
in patients with advanced stage cancer. Arch Gen Psychiatry 2011;68:71-8.
15 Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of
psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry
2006;67:1735-40.
16 Johnson MW, Garcia-Romeu A, Cosimano MP, Griffiths RR. Pilot study of the 5-HT2AR
agonist psilocybin in the treatment of tobacco addiction. J Psychopharmacol
2014;28:983-92.
17 Bogenschutz M, Forcehimes A, Pommy J, et al. Psilocybin-assisted treatment for alcohol
dependence: a proof-of-concept study. J Psychopharmacol 2015;29:289-99.
18 Sewell RA, Halpern JH, Pope HG. Response of cluster headache to psilocybin and LSD.
Neurology 2006;66:1920-2.
19 Nutt DJ, King LA, Nichols DE. Effects of schedule I drug laws on neuroscience research
and treatment innovation. Nat Rev Neurosci 2013;14:577-85.
20 Hari J. Chasing the scream. 1st ed. Bloomsbury Publishing, 2015.
Cite this as: BMJ 2015;350:h2902
© BMJ Publishing Group Ltd 2015
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BMJ 2015;350:h2902 doi: 10.1136/bmj.h2902 (Published 26 May 2015) Page 2 of 2
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... For instance, psilocybinonly produced by one licenced pharmaceutical company in the UK, COMPASS Pathways PLCis priced at £100,000 per 1 g (Johnson, Garcia-Romeu, Cosimano, & Griffiths, 2014). Fourthly, given the social stigma surrounding the topic, most research depends on private sources of funding, which are a very unreliable and unstable source of income (Rucker, 2015). These hurdles increase the financial burden and consume valuable research time, becoming increasingly challenging the more restrictive the category. ...
... For instance, literature on LSD and psilocybin shows growth with periods of decay (Figures 2b and 4b). Research on these substances was on the rise during the 50s and 60s, but underwent an important recess in the 1970s (Figures 2b and d, 4a and b) after a series of sociopolitical events (Figure 1) (Lawrence et al., 2021;Rucker, 2015). Additionally, the literature on MDMA also exhibits growth with periods of decay. ...
... In the UK, the brewing industry sponsored anti-MDMA campaigns due to the negative impact it was having on their business (Carey, 1997). Given the instability and shortage of funding sources to study Schedule I compounds, the ban together with the unfavourable propaganda against MDMA impacted its research (Rucker, 2015). These limitations seem to explain the pattern of growth of the number of papers on MDMA per year, which increased through the 1980s and early 1990s, but stagnated and dropped after 1995 (Figures 2 and 4). ...
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... Considerable evidence shows that the MDR (2001) are not based on the scientific evidence of the risks of these drugs (Nutt et al., 2010;Rucker, 2015). For example, an extensive and detailed Multi-Criteria Decision Analysis (MCDA) of 20-legal and illegal-drugs found that those in S1, such as LSD and psilocybin, were the least harmful to both users and society (Nutt et al., 2010) Counter-intuitively, S2 drugs, most notably heroin, cocaine and amphetamines, scored significantly higher on all 16 harm criteria. ...
... As a result, more methodologically sound research is needed for definitive conclusions to be drawn. However, due to the MDR (2001), there are many practical, financial and bureaucratic barriers to conducting this research (Rucker, 2015). In a survey of members of the UK's leading psychopharmacology organisation, the British Association for Psychopharmacology (BAP), the most reported barriers to research were found to be the cost of S1 CD licenses, storage and security requirements, transportation difficulties, and penalties for not adhering to the guidelines (Freeman et al., 2018). ...
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... Recently, voters in Oregon in the USA decriminalized psilocybin and granted it treatment status for therapeutic use in licensed medical facilities, under the supervision of trained professionals. Indeed, legal reclassification would expedite the clinical research programme needed to integrate high-quality psychedelic therapy into public psychiatry for the benefit of those with non-psychotic mental health disorders [90,91]. ...
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