| ISCD suggested minimum data set for any new drug that raises concerns about harms |
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Background Last year saw major changes in the regulation of some new drugs. Mephedrone and naphyrone plus related compounds were made illegal following a wave of media hysteria with minimal knowledge of their pharmacology and toxicology. Despite newspaper and police implicating the drugs in several deaths subsequent coroners reports have revealed these claims as fictitious and there is still little evidence of significant harm from either drug. Indeed some evidence suggests that a switch from cocaine to mephedrone use may have significantly reduced deaths from cocaine. Despite the banning of these drugs, or maybe because of it, over 41 new synthetic substances were detected last year. Clearly this wave of new drugs presents a challenge to society: Are they safe? Should they be banned? The ISCD is a charitable body that has been set up to provide the truth about drugs i.e. politics-free evidence on drugs including alcohol and tobacco. It has given some consideration to the way in which the UK might deal with this change in drug related behaviour in the light of new synthetic compound being readily available over the internet and makes the following suggestions. It may well be appropriate as a harm reduction measure to ban new synthetic substances that are being sold for recreational purposes if they are particularly harmful. However given the possibility of perverse consequences of such a ban, before drugs are banned some basic information on their pharmacology and toxicology should be obtained so that any ban is well founded in science and likely to do more good than harm. The basic knowledge requirements for any drug in order to assess its potential harms There are certain critical facts that should be known about any drug before it can be considered for control under the MDAct 1971. To obtain this information other procedures are necessary, especially the production of a pure supply of the compound for scientific enquiry. The required data are set out below. Pharmacology Test the drug at receptors, transporters and enzymes (including CYP450s) likely to be relevant – e.g. opioid, amine, GABA, glutamate, some peptides eg opioids - To allow comparison with known drugs Basic toxicology • A measure of toxicity eg LD50 • A general behavioural screen such as Irwin test over wide dose range • Basic interactions with a range of other drugs commonly used including alcohol nicotine cocaine MDMA amphetamine ketamine benzodiazepines opioids Establish minimum dose/brain concentration for psychoactive effect Human psychopharmacology Capture known subjective reports through questionnaires of users - basic effect - subjective classification (euphoric analgesic; hallucinogenic analgesic; CNS depressant; stimulant; euphoric empathogen.etc ..) The npSAD procedure for estimating the true contribution of drugs deaths should also be used to properly evaluate the real contribution of the drug to deaths. Ideally - and especially if there are widespread use and serious public health concerns 1. Establish principle metabolites and perhaps elimination half-life (comparative or human) 2. Measures of abuse liability in rodents – drug discrimination – possibly in some cases drug self administration 3. Tolerance and dependence liability - Chronic dosing studies (3+ weeks at an effective dose) to explore potential accumulating toxicity and withdrawal effects Chemistry In order to conduct these tests a source of the drug is required. We recommend obtaining, by synthesis if necessary, pure compound, at least 100 gm – for use as a standard and for testing per below. The pure compound should also be used to establish basic analytical-chemical criteria such as: aqueous solubility, volatility (i.e. is it potentially smokable?), gas-chromatography/mass spectrometry, I.R. spectrum, reaction with field tests (e.g. Marquis reagent) and cross-reactivity to standard (e.g. amphetamine, methylamphetamine) immunoassays. Since almost all of the substances of interest are bases, and are usually found at street level as hydrochloride salts, then the latter should be synthesised. Detection In addition some means of detecting new drugs should be introduced. This could be a regional drug testing system such as the DIMS one set up in the Netherlands which has the dual purpose of monitoring what drugs are being used and warning users of the dangers of them. Current sources of information such a testing of amnesty bins at clubs should be given guaranteed funding support to allow expansion of testing. Test purchases from the web should made more extensively. We believe that for fair and just decision on whether or not to make the possession or sale of a drug illegal this minimal set of data should be collected. The costs would not be great and could be significantly reduced if the work was supported on a Europe-wide basis. |