Marijuana: Another Human Clinical Trial but With No Consent Form

Bertha K. Madras, PhD

The United States is on the threshold of yet another national experiment, a human clinical trial, to test the health and safety of yet another drug, marijuana.

The first experimental trials with psychoactive drugs began in the late 19th century, following the extraction and proliferation of active compounds in opium and coca plants. Over-the-counter use of heroin, smoked opium, morphine and cocaine died within a few decades in the early 20th century, with an exponential and unacceptable rise in human behavioral and biological calamities that elicited an aggressive response from the medical, legal and legislative communities. The “War on Opium” led to a greater than 90% reduction in opium use internationally starting in the early 20th century and onward. Since then, the popularity of illegally obtained heroin and cocaine has risen and fallen with public perception, but the heroin excursions affect much smaller populations than at the turn of the 20th century. We will never have an accurate tally of the human, legal and economic costs that arose from the legal promotion and proliferation of heroin or cocaine in the few decades that these drugs were widely available. Populations currently addicted are relatively small, but the grim consequences persist and are visible.

The second experiment with another chemical class of psychoactive drugs, amphetamines, emerged in the 1930’s. This wave petered out by the late 1960’s, as data on its hazardous effects (e.g. addiction, psychosis) shifted public perception and led to legal constraints, especially with over-the-counter pills. Use of amphetamines (e.g. methamphetamine and ecstasy) once again rose in the 2000’s and then declined to current relatively low levels, partly because of supply reduction strategies (e.g. tightening of precursor availability, international cooperation) and increased perception of harm (addiction, brain toxicity).

The third experimental wave, hallucinogen use (e.g. LSD) in the 60’s, waned within two decades, conceivably as a result of “bad trip” publicity, enduring psychoactive effects, and restrictive legislation. The 1960’s also witnessed a surge in marijuana use in tandem with other drugs. Its use has fluctuated since then, rising and waning as perception of harm and cultural norms change.

Manifestly, the brain is the repository of our humanity. Drugs compromising brain function, cognition and behavior require a unique form of vigilance to protect public health and safety. The behavioral, psychiatric and biological outcomes of these naturalistic human experiments led to legislative actions embodied by the Controlled Substances Act (CSA) of 1970. The CSA regulated the manufacture, importation, possession, use and distribution of psychoactive substances. The Act assembled all psychoactive drugs under a single rubric and ranked them in five categories or Schedules on the basis of potential for abuse and medical use. Marijuana was placed in the most restrictive Schedule I category, as a substance with high abuse potential and no medical use.

Current Federal law prohibits the sale, distribution and possession of the hallucinogen-intoxicant-sedative marijuana, a decision driven by unacceptably high biological,

medical and behavioral risks (e.g. intoxication, cognitive impairment, sensory, auditory and temporal distortions/hallucinations, vehicular or workplace accidents, others). The status of marijuana has now entered a new, decentralized phase in American and international culture. Billionaire-funded, disingenuous, and proliferating state ballot initiatives are swelling legal access through the guise of medical marijuana laws, or decriminalization, or outright legalization. This accelerating access by the ballot box is associated with a tandem decline in public perception of harm and a rise in marijuana use and use disorders. The financially-endowed movement has catalyzed yet another naturalistic, uncontrolled, human experiment with the drug. This clinical trial requires no informed consent, no signatures approving human experimentation, no oversight from a professional Institutional Review Board, no protections of the Nuremberg Code, the Helsinki Declaration or the Belmont Report, and no legal or financial recourse for bad outcomes. No effective prevention strategy is in place for our most vulnerable population – youth. The experiment may last a few decades and the laws conceivably will be reversed, as even more data on human consequences pour in and society deems them too costly to bear. In the meanwhile, a generation of susceptible youth may be transformed by the drug’s consequences: addiction, IQ reduction, psychosis, cognitive impairment, educational underachievement. They will have no legal recourse with the perpetrators of this human biological experiment, as do participants in a clinical trial.

Source: Bertha K Madras, PhD Professor of Psychobiology Department of Psychiatry
Harvard Medical School bertha_madrashms.harvard.edu April 201

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