Dear reader, perhaps in your travels you have encountered the argument that cannabis has no medical use because the Food and Drug Administration has not approved it. Perhaps you wonder how it is that the Drug Enforcement Administration can plausibly assert that cannabis has no medicinal value notwithstanding the existence of state medical cannabis laws in sixteen states and the District of Columbia and the cascade of articles asserting that yet another study has reported another therapeutic use of cannabis. You read articles in the popular press that report on medical cannabis advocacy and then duly and docilely report that the federal government maintains that there is no medical use of cannabis – and you wonder how the feds could be so obtuse.
They are not being obtuse. They have interpreted the law so that cannabis will always fail their tests and they can then claim legal justification to keep cannabis prohibited forever.
I intend to deconstruct this issue and explain the legal reasoning of the DEA. When you finish this article, which I am splitting into several posts because of its length, you should be able to challenge the official government position, recited incessantly by prohibitionists in federal, state and local governments as well as the prohibitionist lobby outside of government. At a minimum you should be able to challenge members of the press to demand plausible explanations of the prohibitionist position.
1. In its public statements, the DEA denies that there is any medical use for cannabis by defining “medical use” as “FDA approval.”
2. In 1987, a federal appellate court, the Court of Appeals for the First Circuit (Massachusetts and the other New England states aside from Connecticut) ruled in the decision of Grinspoon v. DEA that this definition is incorrect: the FDA’s approval of the right to market a drug (which requires a showing to the FDA’s satisfaction through extensive and expensive clinical trials that a drug is “safe” and “effective” for some specific use) is not the same showing that the drug has a “a currently accepted medical use in treatment” under the Controlled Substances Act. Therefore, the absence of FDA approval does not require a conclusion that the drug has no medical use.
No matter – in 1988 the DEA came up with a new definition that means practically the same thing: now it requires that anyone proposing a medical use of cannabis (or any other in the same legal category, such as MDMA, LSD, psilocybin, ayahuasca and ibogaine) must show that there have been clinical trials of the type which the FDA requires in order to approve a drug for marketing. Obviously, requiring that someone seeking to demonstrate a medical use for a psychedelic show the results of the extremely expensive and demanding Phase III clinical trials that meet the FDA’s criteria to obtain approval have taken place is functionally the same as requiring FDA approval. Further, there is no basis whatsoever for this standard in federal law: the DEA made it up out of thin air. We will examine this matter more fully later and consider that the DEA is requiring a form of efficacy evaluation that does not exist in US law.
3. It gets worse: the DEA has refused even to hold hearings at which evidence of medical use can be presented. Even though there is no requirement in federal law that someone seeking to show that there is a medical use for cannabis prove the existence of that use before a hearing, that is exactly what the DEA requires – again, in the form of the equivalent of FDA approval.
4. There is another minor additional complication in this picture: (a) not only is there no basis for DEA’s requirement that a proponent of a medical use for cannabis demonstrate the existence of that medical use before there can be a hearing as to the existence of a medical use and (b) not only does the DEA’s definition of medical use as FDA-compliant Phase III clinical trials defy the First Circuit’s 1987 decision but (c) the DEA’s position (I argue) violates Constitutional principles of federalism as established by the US Supreme Court in the decision of Gonzales v Oregon.
I am not on touching on another major element of the DEA’s current position: its switcheroo in which, for the purposes of denying the most recent petition to reschedule cannabis, it changed its requirement that “the drug be accepted by qualified experts” to a requirement that there be a “consensus of qualified experts,” i.e. that there be no “material conflict” of opinion among experts.” In other words, as state medical cannabis laws spread, the DEA makes its definitions more restrictive in order to deny any medical use and thereby insist that cannabis remain completely prohibited.