Future Presentation – Technological Approaches in the Synthesis of Designer Drugs, and Creative Prosecution of the Non-Scheduled, Illicit, Analog Drug
Annual Meeting of the American College of Legal Medicine – Las Vegas, NV,
Presentation Date: February 27, 2015
“Technological Approaches in the Synthesis of Designer Drugs, and Creative Prosecution of the Non-Scheduled, Illicit, Analog Drug”
(Accepted for presentation at the 2015 annual meeting of the American College of Legal Medicine, Feb. 27, 2015, Las Vegas, NV))
The current use of the term “designer drug” evolved from the 1980s when drug dealers attempted to synthesize or design opioids which were not listed in the Controlled Substances Act (CSA) of 1970, thus interfering with the ability of the US federal government to prosecute distributors and users of such drugs because these “designer drugs” were not listed in the CSA.
During the 1980s, ecstasy (MDMA, 3,4-methylenedioxymethamphetamine) became popular and also was described as a designer drug since it was not listed in the CSA. In order to prosecute distributors and users of ecstasy, federal laws were rapidly passed to give the Drug Enforcement Agency (DEA) the power to emergency schedule non-listed chemicals like ecstasy under the CSA for a year, with an option to extend the designation for 6 months. Emergency-Scheduling power was used for the first time to schedule ecstasy as a Schedule I drug, despite a federal judge’s opinion that ecstasy actually should be classified as a schedule III drug, based on an accepted medical use at that time. Since the 1980s, the toxicity of ecstasy has become well-established, and any therapeutic use has been discontinued, and ecstasy now is correctly categorized as a Schedule I drug.
During the late 1980s and early 1990s the United States saw methamphetamine or “crystal meth” emerge as a widespread public health problem. The government enacted laws to track the sale of precursor chemicals for methamphetamine, like phenyl-2-propanone (P-2-P) and pseudoephedrine, in an attempt to cut down on the manufacturing of methamphetamine, as portrayed in the well-known TV show, “Breaking Bad.” As a result alternative stimulant drugs emerged, with cathinones like 3,4-methylenedioxypyrovalerone (MDPV), 4-methyl-methcathinone (4-MMC or mephedrone), and 4-methylephedrone (methylone) all used as possible principal active ingredients in “bath salts”, which were sold over-the-counter and labeled “not for ingestion.” MDPV was found most commonly in the US and mephedrone was found more commonly in Europe. Cathinones comprised the active ingredient in “khat,” a plant which people would chew in order to extract the active alkaloid and derive a stimulatory effect. Physiological effects of cathinones include CNS stimulation, hypertension, agitation, anxiety, sweating, tachycardia, and vasoconstriction, and psychiatric symptoms include psychoses, self-injury, suicidal ideation, hallucinations, confusion, panic attacks and paranoia, all reminiscent of amphetamine-like effects.
Since 2005, great attention has been focused on a mixed group of drugs called “Synthetic Cannabinoids,” (SC) sold over the counter at truck stops, “head shops” and over the internet in the US, as “Spice,” or “K-2” and promoted as a “legal marijuana” because they were not listed in federal or state controlled substances’ statutes. In fact, these compounds bore little resemblance to the chemical structure of tetrahydrocannabinol (THC) and are most commonly indole derivatives, more closely related to LSD and DMT in chemical structure, as the THC molecule contains no N atom. “Common untoward medical effects associated with SC
use have included elevated heart rate/blood pressure, hallucinations, agitation/anxiety, hyperglycemia, nausea, vomiting, hypokalemia, and seizures (Papanti et al, 2013). Many acute psychotic reactions have been reported, and fatalities are not uncommon.
In order to circumvent the fact that these “designer drugs” (i.e., designed to differ from drugs listed in the statutes) were not listed in the CSA, in 1986, Congress passed The Federal Analog Act (U.S.C. § 813), a section of the US Controlled Substances Act which allowed any chemical determined to be “substantially similar” to a controlled substance listed in Schedule I or II to be treated as if it also were listed in those schedules, but only if intended for human consumption.
In order to be classified under the Act, a substance had to meet 2 of the following criteria:
(I) the chemical structure of which is “substantially similar” to the chemical structure of a controlled substance in schedule I or II; and
(II) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or
(III) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II.
Substantially similar is both:
(1) a readily cognizable similarity between the alleged analog and the controlled substance prior to ingestion, and (2) metabolism of the alleged analog into the controlled substances after ingestion, e.g., 1, 4 – butanediol –> gamma-hydroxybutyric acid (GHB).
In the case of USA v. Damon S. Forbes et al. (1992) 806 F.Supp. 232, a district court in Colorado considered the question of whether the drug alphaethyltryptamine (AET) was a controlled substance analogue of the tryptamine analogues, dimethyltryptamine (DMT) and diethyltryptamine (DET). In this case, the court ruled that AET was not substantially similar to DMT or DET.
In the case of USA v Washam (2002) 312 F.3d 926, 930, an appellate decision for the eighth judicial circuit considered whether the drug 1,4-butanediol (1,4-B) was a controlled substance analogue and was substantially similar to gamma-hydroxybutyrate (GHB). In this case, the court ruled that 1,4-B was substantially similar to GHB.
Writing in the Ohio State Journal of Criminal Law, (posted on the Internet without a citation) Hari Sathappan, a second year law student at Moritz College of Law, wrote that “substances are considered “scheduled” when they are listed in 21 U.S.C. § 812, and 21 U.S.C. § 841 makes it illegal to knowingly or intentionally distribute a controlled substance. In order to indict under § 841, the substance in question must be scheduled…. According to the Federal Analogue Act (21 U.S.C. § 813), ‘analogues’ shall be treated as a controlled substance, so long as the analogue is intended for human consumption.”
Even using the criteria set forth in the Federal analog act, great confusion exists among qualified experts with regard to how to conduct a comparative analysis of two chemicals to determine if the non-scheduled drug is substantially similar to the schedule drug. More than 200 SC’s have been synthesized, and forensic laboratories have not developed analytical procedures to qualitatively identify all of these drugs. SC’s do not test positive in typical cannabinoid screening tests, and identification of all SC’s, either in a packaged form or in biological fluids, at this time is not possible. This further complicates and confounds the ability of prosecutors to indict and prosecute those individuals either using or distributing SC’s.
Using generally accepted methods of pharmacology, psychopharmacology, medicinal chemistry, structure-activity relations (SAR), and organic chemistry, this presentation will set forth a method which can be used, with reasonable scientific certainty, to determine if a non-scheduled drug is substantially similar to a scheduled drug. The author will also present an analysis of Damon and Washam introduced above. After attending this presentation, practitioners of legal medicine should be able to define a designer drug, and recognize how the Federal analog act can be used to prosecute manufacturers, distributors, and users of designer drugs. Practitioners of legal medicine also will become familiar with the adverse CNS effects of “bath salts” (cathinones) and “synthetic cannabinoids” (e.g., “Spice” and “K-2”).