Prohibition or Coffee Shops: Regulation of Amphetamine and Methylphenidate for Enhancement Use by Healthy Adults

Abstract

This article analyzes appropriate public policies for enhancement use of two most important stimulant drugs: Ritalin (methylphenidate) and Adderall (mixed amphetamine salts). The author argues that appropriate regulation of cognition enhancement drugs cannot be a result of a general discussion on cognitive enhancements as such, but has to be made on a case-by-case basis. Starting from the recently proposed taxation approach to cognition enhancement drugs, the author analyzes available, moderately permissive models of regulation. After a thorough analysis of relevant characteristics of methylphenidate and amphetamine, the author concludes that a moderately liberal permissive regulation of enhancement use by healthy adults might be appropriate for extended release forms of methylphenidate. However, due to their danger profile, amphetamine and instant release forms of methylphenidate should not be made readily available to healthy adults and would need to be prohibited.

Keywords:

• cognitive enhancement
• public policy
• amphetamine
• methylphenidate
• autonomy
• neuroethics

Notes

Most authors argue about what criterion or which ethical standpoint should be used while assessing CED (for an overview see Glannon 2008), and while there are some discussions of concrete policy options (e.g., British Medical Association [BMA] 2007; Dubljevic 2012b), the debate is still very much abstract. However, there are some important contributions noting the urgency (e.g., United Nations Office on Drugs and Crime 2007) and difficulties of regulating CED (e.g., Coenen, Schuijff, and Smits 2011; Greely 2011).

The current prohibitive response of the state even on the issue of illicit drugs such as heroin seems to be discredited—see, e.g., Husak (2005; 2007), Duke and Gross (1993), and De Greif (1999). However, for important dissenting opinions see, e.g., Wilson (2007) and De Marneffe (2005). It has to be emphasized that even the dissenters agree that the current prohibition regime is too harsh and costly, especially in cases of relatively harmless drugs (e.g., cannabis).

Furthermore, different models of general policy types can and should be proposed and analyzed in the context of a specific case, and some might be legitimate while others, such as blanket prohibition with punitive sanctions for production, sale, possession, and use, might not. I return to this point in the last section.

It should be noted here that the “gatekeeper” approach for enhancement use by healthy adults, i.e., allowing use to some by prescription, does restrict personal choice, and has recently been criticized as paternalistic, illegitimate, and untransparent (Dubljevic 2012b), and largely ineffective as a form of regulation (Dubljevic 2013). This effectively reduces the legitimate models of the “discourage use” policy to some kind of taxation approach. Furthermore, prescription of methylphenidate and amphetamine as therapy should be dissociated from the regulatory framework for use of these substances by the healthy, which is the topic of this article.

In this and the next paragraph I draw on Euromonitor (2011).

A pack of 20 cigarettes costs 90 NOK (the equivalent of 16 USD) in Norway, and two-thirds of the price (60 NOK) is taxes (see http://www.newsinenglish.no/2012/05/14/duty-free-tobacco-comes-under-fire). When this is compared with the highest taxation rate in the United States, the one in force in New York, the “heaviness” of taxation in Norway becomes clear: In New York City, a pack of cigarettes costs 11.9 USD and the total tax on a pack of cigarettes is 5.85 USD (see http://www.huffingtonpost.com/sheelah-a-feinberg/bloomberg-tobacco_b_1542965.html).

In this paragraph I draw on Staatsblad (2002).

Although Ritalin is the most famous form of methylphenidate, a variety of formulations and (generic) brand names exist. Among these, instant-release (Ritalina, Rilatine, Attenta, Medikinet, Metadate, Methylin, Penid, Rubifen, and Focalin), and extended-release formulas (Equasym XL, Medikinet XL, Metadate CD, Ritalin LA, Rubifen SR, Ritalin-SR, Methylin ER, Metadate ER, methylphenidate SR, Concerta, Watson methylphenidate ER, and Teva-Methylphenidate ER-C) should be distinguished due to different abuse potential. In what follows I draw extensively on Iversen (2008). Unless otherwise noted, this is the source of data in this section. I try to keep the discussion as understandable as possible for a generally educated, nonexpert reader.

Amphetamines are a very diverse class of drugs. On the one hand, some amphetamines are medical drugs with legitimate health benefits and regulated purity (e.g., Adderall, Adderall XR, Dexedrine, DextroStat). On the other hand, some amphetamines are illicit drugs known by their street names (e.g., speed) with shifting amounts of various substances (see EMCDDA 2010). To complicate matters further, some drugs (such as Captagon) are originally medical drugs acting as precursors of amphetamine (i.e., the human body metabolizes the initial substance into amphetamine), which have gained popularity in the underground scene and then moved entirely into illicit traffic (see EMCDDA–Europol 2011). Furthermore, many discussions include methamphetamine and other substances in the class of amphetamines (see, e.g., Freye 2009), which decreases clarity. Methamphetamine has effects different from and greater toxicity than amphetamine, and is not used as a CED, but only for recreational purposes. Generally, the discussion will be limited to medical drugs containing amphetamine (e.g., Adderall) in the strict sense with regulated purity and that are used for enhancement purposes by healthy adults.

The data on effects of amphetamine use with no sleep deprivation from the Table 1 should be taken with a dose of caution: A recent study (Illieva, Boland, and Farah 2013) did not find any reliable effects of mixed amphetamine salts on a range of cognitive tasks in a fully rested state by 46 Caucasian young healthy adults, while they reported reliable effects on perceived enhancement effects. However, they noted that participants are not representative of the general population (in addition to the restricted age range, they met a number of health and lifestyle criteria for inclusion, including never having used stimulants and low use of coffee), and that only a single dose (20 mg) of a single form of amphetamine has been used.

This should also be taken with a dose of caution. The safety of these drugs has been established for treating defined conditions under supervision by a medical professional. Safety of a drug for over-the-counter use by healthy adults is something that would have to be further tested.

The data on danger profiles from Table 2 should be taken with a dose of caution. Even though there is a lot of overlap between qualitative assessments of harms in the relevant literature (e.g., Bigelow 2006; Iversen 2008; Miller 2002) and institutional documents (e.g., EMCDDA 2010; UN 1971) and quantitative assessment in the table, experts can be biased in favor or against certain substances. However since this is the only available source of quantified values of drug harms, there is no choice but to rely on it, and to advise that further studies (i.e., assessments by different stakeholders) will be needed.

According to Articles 29 and 30 of the United Nations 1971 Convention on Psychotropic Substances, every country has the right to denounce the convention entirely or to propose amendments. However, this is not the only way to propose regulatory change. Article 3, Paragraph 2, explicitly states: “If a preparation containing a psychotropic substance other than a substance in Schedule I is compounded in such a way that it presents no, or a negligible, risk of abuse and the substance cannot be recovered by readily applicable means in a quantity liable to abuse, so that the preparation does not give rise to a public health and social problem, the preparation may be exempted from certain of the measures of control provided in this Convention.”

Of course, bearing in mind the vested interests of both pharmaceutical-industry and anti-Ritalin lobbies, such conclusions should never be based on a single study. However, Merkel et al. (2007) report that most empirical studies have the finding that methylphenidate treatment actually decreases the risk of developing substance abuse disorders (four of these are quoted), while others have found no correlation whatsoever (again, four studies are quoted, and among them Barkley et al. 2003). According to Merkel et al. (2007), only one study has found an increased risk, but the results of this study have not been replicated, so the claim that there is no correlation that would support a “gateway” drug argument is fairly uncontroversial.

Actually, Miller (2002) reports that methylphenidate is correlated with lower than normal incidence of cancer. Therefore, the claim that methylphenidate does not increase the risk of developing cancer in humans is fairly uncontroversial. However, this might point toward the conclusion that tobacco is inadequately regulated, and that an analogy between tobacco and methylphenidate regulation would not be appropriate. This objection is tackled in the last section addressing self-harm and risks of abuse.

The United Nations 1971 Convention on Psychotropic Substances is extremely important since it shaped the development of the global drug control regime. States that have signed this convention (i.e., the majority of UN member states) have very similar domestic legal frameworks for regulation of psychotropic substances, due to compliance with the convention. For example, in the United States, the Psychotropic Substances Act of 1978 explicitly ensures compliance with the convention: “It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose” (21U.S.C.§801a). Furthermore, the UN Convention on Psychotropic Substances of 1971 should not be confused with the UN Single Convention on Narcotic Drugs of 1961, which shapes regulatory frameworks for opiates (including cannabis). The ambiguous language in this treaty makes it unclear whether or not it requires criminalization of drug possession for personal use, which is a fact exploited by the Netherlands, one of the signatory states. However, the language in the 1971 convention is unambiguous: Individuals can only use Schedule II substances (including methylphenidate and amphetamine) with a special permission.

A further point needs to be explained here. Based on data from Table 2 it could be assumed that amphetamines are not really addictive. However, recall that the physical dependence rating reflects the increasing tolerance (higher dosage is needed to produce the desired effect), intense craving, and withdrawal reactions when the drug use is stopped. Amphetamines do not cause withdrawal reactions, but do cause intense craving and tolerance, so the rating is 1.1. However, the facts that use can be highly pleasurable (2.0) and that use can cause psychological dependence (1.9) make the threat of addiction very real, especially if these are abused.