A historical context will provide the basis for understanding how scientists develop and change their standards for evaluating the significance of scientific data. The standards are provided by paradigms that guide scientific research. This issue concerns the paradigm that guides research on marijuana and its constituent parts. The U.S. government can not recognize this paradigm’s validity in a scientific context, such as the awarding of grants by the National Institute on Drug Abuse, and reject the paradigm’s validity in an administrative rule-making procedure.
Here is DEA’s description of the historical background of the paradigm they are using to evaluate scientific data about marijuana.
“In 1901, Congress intervened with the passage of the Food, Drug and Cosmetic Act (FDCA). A shift began away from anecdotal evidence to objectively conducted scientific research, away from uninformed opinions of lay persons and local doctors to expert opinions of specialists trained to evaluate the safety and effectiveness of drugs, and away from totally democratic decision-making to oversight by the Federal Government.”(15)
DEA maintains that the paradigms developed to evaluate manufactured pharmaceutical substances indicate that marijuana is too unstable for medical use.
“Modern drug-research is based on the use of well-defined preparations of pure compounds which, when administered to patients, allow reproducible results. The problems associated with using natural substances as drugs include the inability to regulate the doses of active constituents, and the interaction of the active constituents with other potentially active compounds in the natural substance. The presence of active constituents with other potentially active compounds in the natural substance. The presence of active constituents in most natural drugs may vary based on genetic factors, county of origin and growing conditions. As a result, most natural drugs cannot meet established quality control standards in the United States. Before a drug substance may be used in the practice of medicine, it must have a composition of active ingredients that has been established and accepted as standard. Such standardization, which includes identity, purity, potency, and quality, is specified in either a New Drug Application (NDA) or an official compendium such as The United States Pharmacopeia or National Formulary.”(16)
The purpose of research, though, is to obtain scientifically valid assertions. Paradigms, like judicial doctrine, changes in the hands of its practitioners. While one paradigm that utilizes pure compounds can not provide valid assertions about marijuana, surely others can. In terms of evaluating dependence, the development of new testing paradigms is one of the functions of the College on the Problems of Drug Dependency (CPDD).
This petition has reviewed several other new paradigms now in use to evaluate the significance of data about marijuana’s effects on health and behavior. The relation of dopamine to addictive behavior has provided a new paradigm for understanding the biological basis for substance abuse. New technologies such as autoradiographic assay techniques, microdialysis, and the development of non-classical cannabinoid isomers produced new research paradigms for studying the human brain. The resultant knowledge created a new paradigm for understanding the significance of experimental research on the effects of cannabinoids in that data can now be evaluated in the context on a known mechanism of action for the substance. Social science is producing new paradigms to understand the abuse and addiction, whether it be the refinement of the gateway theory to incorporate Jessor’s observation that heavy drinking is an intermediate step between marijuana and hard drug use, or further application of Zinberg’s theories of drug, set and setting. The use of data on marijuana’s constituent parts, however, as the basis for making scientifically valid generalizations about marijuana has been a scientific convention since Mechoulam and Gaoni discovered the structure of D9-THC in 1963.