Regulating Pleasure: Choosing Regimes for Psychoactive Drugs Peter Reuter University of Maryland 1.

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Regulating Pleasure: Choosing Regimes for Psychoactive Drugs

Peter ReuterUniversity of Maryland

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Motivation

• Marijuana legalization now serious policy option– US movement driven mostly by dissatisfaction with

apparently tough enforcement– Also potential state revenues– Importance of substitution with other substances

• New psychoactive substances (NPS) present similar issues:– How will NPS affect total mix of psychoactive substances?– Are gains from allowing legal distribution merely

elimination of the harms associated with the prohibited?

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New, attractive psychoactive substances are produced increasingly frequently….

• Single convention listed 85 prohibited substances in 1961 and 282 by 1995– Shulgin: 2 psychedelics in 1900 (mescalin and

marijuana), 20 in 1950, 200 in 2000• Growing number of competent chemists– Particularly in countries with weak regulations

• Technologies make innovation easier• Globalization (of course)

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…and present a regulatory challenge

• Require decisions when scientific knowledge limited

• Though they are not intended as medicines current system (US, Europe, Australia) treats them as potential therapeutic drugs– Either enter pharmacopeia or prohibited

• Is there an alternative system that would produce results reflecting more elements of social wellbeing?

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Recent experiences with new substances follow common pattern

• Substance enters grey market through variety of marketing channels– Internet, boutique stores etc., with false label – E.g. “not intended for human consumption”

• Increasing number of reports of some adverse effects

• A small number of highly publicized fatalities with confused etiology

• Review leads to prohibition

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NPS often linked

• Ecstasy market generating low quality drugs– Often contains other active ingredients

• Mephedrone developed partially to provide reliable source of Ecstasy-like experiences

• Following mephedrone scheduling in UK, naphyrone developed – alternative means of dumping mephedrone

through mislabeling

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ACMD reasoning for scheduling Naphyrone

• Exculpatory:– “[N]o confirmed cases of acute toxicity associated with the use of

naphyrone.” – “[No known] relationship between naphyrone and anti-social

behaviour or acquisitive crime.”• However

– Drugs marketed as naphyrone often contained other drugs – Large differences in dose size between naphyrone and the drugs

often sold under that name – Effective dose size of naphyrone so small (25 mg.) that many users

likely to take dangerously high doses• All these considerations distinct from clinical trials outcomes

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BZP in New Zealand best studied NPS

• BZP not prohibited when it became popular and widely promoted in NZ ca. 2002

• 2005 law created restrictions on promotion and banned sales to under 18– Widely flouted– Tacit permission for production and sales to adults

• Survey in 2007 found 5.6% used in previous 12 months (4th most popular)– Many believed drug was approved by government

• Government scheduled drug in 2008– Large decline in prevalence

• PSA passed in 2013– Full implementation only begins in Nov 2014

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Challenge of establishing risk for PSA

• Six components – Toxicological effects – Risk to public health – Potential to cause death– Potential to create dependence– Likelihood of misuse – Appeal to vulnerable populations

• What acceptable level of risk in each domain?– What is cost of assessing?

• Small country not ideal for initial test because such testing has high fixed costs

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EU lists broad set of criteria for assessing new substance (2005)

• “An assessment of risks caused by use of, manufacture of, traffic in a new substance as well as the potential involvement of organized crime.”

• The risks to be assessed include social and health risks as well as the consequences of potential control measures.”

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Implemented system much simpler

• EU list strains analytic capacity– For example, how could organized crime

involvement be predicted? • Instead uses standard assessment of drug

scheduling decisions: Is this substance safe and medically useful?

• Cannot pass the test of being the preferred treatment for a specified medical condition

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Decisions must be made on meager scientific evidence

• Example: “There is an absence of standard safety pharmacology and toxicology data. …..Many BZP tablets and capsules also contain TFMPP (1-(3-trifluoromethylphenyl) piperazine)…..most users consume BZP with alcohol as well as other psychoactive substances.” (EMCDDA, 2007; p.4)

• Who has incentive to fund large scale studies of epidemiology and effects of drug?

• On what basis does the regulator project the future trajectory of use of BZP and related substances?– Hard/impossible to do even with well studied substance

such as cocaine and alcohol

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Other regulatory complications

• If, despite label warnings, it is predictable that users will take alcohol simultaneously with BZP, should that figure in the risk assessment?

• Prohibition may cause additional harms but how can they be projected for analysis in a public and transparent fashion?– Harms from prohibition very drug-specific

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Problem modest in most countries• UK 1700 treatment entries in 2013/14 out of 64,000 total

treatment entries– 52 deaths out of 1699 total

• European Commission lists 80 new substances for review in 2013

• Many NPS briefly prominent but few last long– Most turn out to be dangerous or unattractive– “It may be that the market, to some extent, regulates itself with less

effective or more harmful NPS only being seen for very short periods of time or in a limited number of countries” (Home Office, 2014)

• US has scheduled only 71 new substances (plus analogues) 1971-2010 (Caulkins and Coulson)– Synthetic cannabinoids may present more serious challenge– 11.4% of high school seniors reported past year use in 2013

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New Substances in Europe (EEWS)

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Last year prevalence of NPS (Britain, 16-59 year olds)

2009/10 2010/11 2011/12 2012/13 2013/14

Mephedrone N/A 1.3 1.0 0.5 0.6

Salvia N/A N/A N/A 0.3 0.5

GBL/GHB 0.1 0.0 0.1 N/A N/A

Spice 0.4 0.2 0.1 N/A N/A

BZP 0.5 0.1 0.1 N/A N/A

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How should Marijuana be regulated?

• Set aside medical uses– Separate regime operating in many jurisdictions

• Marijuana has known risks– Addictive – Source of accidents– Early, heavy use has long-term and serious

behavioral consequences (Dunedin study)• Would fail test under EU NPS regime

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Marijuana legalization case rests primarily on harms averted

• Police use marijuana possession arrests to control minority communities

• Prohibition generates large black markets – Corruption and violence in Mexico

• Buying marijuana increases youth contact with other illegal drugs

• Concern about rising THC content– Declining CBD

• Prohibition fails to make drug expensive or inaccessible• Government revenue the one positive element

Marijuana readily available to youth

Drug 1994 2012

cocaine 46.6 29.8

amphetamines 60.2 45.4

heroin 34.1 19.9

Marijuana 85.5 81.6

Percent of high school seniors reporting drug readily available or somewhat available

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Wide range of possible legal regimes

• Potential regimes– Grow your own (Colorado, Uruguay)– Clubs (Spain, Uruguay)– State monopoly (no advertizing)– Private enterprise (Colorado, Washington)

• Three policy decisions drive consumption– Price– Promotion– Access

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How will legalization affect public health?

• Prevalence will rise– Price and access effects

• Public health consequences reflects more than prevalence– Product innovation also important– Ratio of THC to CBD

• Substitution for heavy drinking critical– Current research on relationship ambiguous– Relationship may be different short- and long-term

• Caution: knowledge about constituent elements of marijuana probably similar to knowledge about tobacco in 1960

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Conclusions

• Regulatory decisions are made at a stage when some harms will be known but assessment will be very incomplete

• Current system gives no weight to pleasures of drug use nor to potential substitution for a more harmful substance (legal or illegal)– Ignores the realities of contemporary life– What if a less harmful substitute for alcohol were available?

• Thus responsible decision makers will have no benefits to balance against known risks

• Result is that it is unlikely that any NPS will be allowed