The dangerous charms of the unknown


Hughes & Winstock [1] move the ‘legal highs’ discussion forward by reviewing regulatory systems other than the traditional drug control apparatus under which these substances might be handled.

Note, first, that the current system may be doing quite well by some important measures. Coulson & Caulkins [2] reviewed the 73 substances that had been scheduled by at least one of four countries (United States, United Kingdom, Australia, Canada). For each substance they asked whether there was evidence that the scheduling decision represented a Type I error; namely, a drug that should have been allowed on the market was scheduled. Using the existing literature they thought that no more than four of the 73 (and probably only one) represented an over-scheduling decision. Type II errors, where a dangerous substance was left unscheduled, obviously cannot be studied by looking at those that were scheduled. Examining the critical literature they found only three unscheduled substances that seemed to be in need of scheduling. As they note, this does not mean the system is perfect, but the claim of a major problem of over-scheduling or under-scheduling, at least for those four countries, is unpersuasive.

The problems that Hughes & Winstock propose to solve, then, are narrower: (i) allowing new substances to properly label themselves as for human ingestion rather than claim deceptively to be something else, such as ‘bath salts’ or ‘plant food’, and (ii) reducing the time to banning the drug if necessary. It is hard to argue with the first of these, but the second may be less attractive than it appears.

Prohibition is not a decision to be made lightly. Admittedly, the existing system has an element of farce. It requires review of what is almost always an extraordinarily thin scientific literature. The novelty of most of these drugs means that there has been little time to conduct research on the health consequences of use, let alone explore the population health consequences of the drug. However, the current system's requirement of elaborate collection and analysis of relevant information, with an emphasis on peer-reviewed material, has some distinct advantages compared to allowing a civil servant to make the decision without public scrutiny. David Nutt has critiqued a number of recent Advisory Council on Misuse of Drugs decisions in the United Kingdom for their excessive caution (e.g. [3]); whether or not he is correct, it is only because of the current drawn-out procedures that the public is in a position to judge this matter.

In addition, there surely must be some concern about the deceptiveness of using the medications system: recreational substances are being permitted under legislation that is aimed clearly at regulating goods that have therapeutic intent. The relevant clause in the European Union legislation is: ‘any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis’.

A recreational drug presumably meets the criterion of ‘modifying physiological functions’, but what does not? The answer may be to expand the relevant legislation so that fitting these new drugs under medications does not require intellectual contortions.

Hughes & Winstock, following Birdwell, Chapman & Singleton [4] point us in an interesting direction. However, in examining the regulatory alternatives we should be sensitive to a potential bias in our thinking. We know very well the complexities and problems of the drug scheduling system. We need to become similarly intimate with the advantages and disadvantages of the alternatives before making a recommendation to shift systems.

Declaration of interests