This is the first part of a two part series. Read Part 2 HERE.
There is much to criticize in the DEA’s recent denial of two petitions to have marijuana removed from Schedule I of the Controlled Substances Act (CSA) and placed in a less restrictive regulatory category, and even a little to praise when it comes to some of the scientific findings buried in the lengthy explanation of their decision.
Nonetheless, the decision not to reschedule marijuana is good news for the marijuana reform movement as it utterly discredits the use of the CSA as a regulatory model for cannabis and sends a clear signal to Congress that new legislation is needed to legalize and regulate marijuana in the United States.
The CSA serves to provide a regulatory framework for proprietary pharmaceutical drugs, which, because of their abuse potential, have a risk of being diverted from regulated to unregulated markets. The CSA can only be effective for drugs with two characteristics: they are manufactured by pharmaceutical companies with limited and easily monitored production, and they are subject to rigorous and capital-extensive clinical studies under supervision of the Food and Drug Administration.
Marijuana does not have these characteristics, and this is why it will not be removed from Schedule I of the CSA by the DEA. This is also why the CSA has been, and will continue to be, an abject failure in respect to providing some measure of control over marijuana’s cultivation, distribution and use in the United States.
The DEA acknowledges this in the two primary findings supporting the denial of these two recent rescheduling petitions, consistent with their reasoning in denying three previous rescheduling petitions (two of which were filed by this author and High Times).
First, they conclude that there are not yet reliable consistent studies establishing marijuana’s medical use, and this finding in part is based on recognition that marijuana is a complex substance with several relevant chemical compounds—thus there is no consistent and standardized form of the drug as with pharmaceutical drugs. Second, the fact that there is widespread use of the drug, despite a lack of legal access, is taken as proof that the drug has a high potential for abuse—which also justifies its current placement in the CSA’s most restrictive schedule.
To many, this creates an obvious paradox—because the drug doesn’t fit the conventional form of a pharmaceutical drug and is widely accepted and used by the public as an effective drug, it can’t be recognized as a drug under the standards embedded in the Controlled Substances Act by Congress. The problem here is not with marijuana, nor with the decisions made by the public, but instead with the standards created by Congress.
Thus, the only remedy to this conflict is for Congress to remove marijuana from the CSA and regulate it via more appropriate legislation.
However, there is a reasonable way to interpret existing legislation to allow the DEA to reschedule marijuana. They have just decided not to interpret the CSA in this way, and the courts will allow them their interpretation as long as it has a reasonable and rationale basis (hence, the lengthy and detailed explanation for their decision published in the Federal Register).
The DEA argues that treaty obligations of the United States under the Single Convention Treaty restrict marijuana’s placement in the CSA to either Schedule I or Schedule II, making the abuse potential of cannabis irrelevant to scheduling determinations. (In other words, they claim they do not need to assess the relative abuse potential of marijuana compared to other drugs regulated by the CSA; it doesn’t matter that marijuana’s abuse potential is lower than that of heroin or cocaine and perhaps similar to drugs in a less restrictive schedule.)
For this, they point to a decision by the U.S. Court of Appeals in response to NORML’s litigation over this argument in the 1970s. The DEA is misrepresenting the court’s decision here. In fact, the court directed the government to conduct a complete scientific and medical review, after which treaty obligations should be examined, and then, if the scientific evidence creates a clash with treaty obligations, the United States should then take steps to change the treaty.
The DEA then argues that marijuana does not meet a list of five criteria for establishing accepted medical use. This is also the result of prior litigation, in which the U.S. Court of Appeals initially rejected the DEA’s decision-making framework. In response, the DEA produced this simplified test, which the court ruled was reasonable.
These criteria are:
1. The drug’s chemistry must be known and reproducible.
2. There must be adequate safety studies.
3. There must be adequate and well-controlled studies proving efficacy.
4. The drug must be accepted by qualified experts.
5. The scientific evidence must be widely available.
The DEA argues that the drug’s chemistry remains complex and has not been standardized, and that “currently, no published studies conducted with marijuana meet the criteria of an adequate and well-controlled efficacy study.”
Keep in mind that the criteria they refer to are those for conventionally manufactured pharmaceutical drugs. Also, their scientific review determined that there are only 11 studies meeting their criteria for review.
“The identified studies examine the effects of smoked and vaporized marijuana for the indications of chronic neuropathic pain, spasticity related to Multiple Sclerosis (MS), appetite stimulation in human immunodeficiency virus (HIV) patients, glaucoma, and asthma,” the report states.
All 11 of these studies had “limitations in their study design” and do not prove efficacy. Instead, “they may be considered proof of concept studies,” providing “preliminary evidence on a proposed hypothesis involving a drug’s effect.” Thus, these studies create a foundation for further research, but what the DEA really wants here are “dose ranging clinical studies.”
The DEA could rely on other criteria to make a determination that marijuana has an accepted medical use in the United States, but they have chosen not to, and the federal courts will affirm their legal authority to use their discretion in this way.
The denial of the current rescheduling petitions, as with prior denials, is based on the DEA’s use of discretion in interpreting relevant court decisions and their predisposition to evaluate marijuana in terms based on manufactured pharmaceutical substances.
But the real problem here is the CSA itself, which was designed to regulate pharmaceutical drugs and prevent legal commerce in marijuana. Rescheduling is a dead-end for marijuana reform, and frankly, that is as much a problem for the federal government as it is for the public in general and marijuana users in particular.
The refusal to reschedule does nothing to resolve the widening gulf between state and federal law and will have little impact on the ongoing emergence of a state-approved, legal, regulated marijuana industry.
There are, however, some interesting admissions contained in the DEA marijuana review regarding the current state of research of marijuana, and these will be reviewed in Part Two of this column.
lol…typical government agency…they say… “First, they conclude that there are not yet reliable consistent studies establishing marijuana’s medical use…” well duh…since its a schedule I drug, medical testing is impossible. So…with that said and the “logic” (using that term loosely)…it will NEVER be removed from a schedule I drug. Idiots.
Great article; I’m looking forward to part two.
This is actually good news; rescheduling puts Big Pharma and the FDA in control. It needs to be descheduled entirely, something Gary Johnson has promised to do in his first month.
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They don’t have enough information about the drug, but they apparently had enough to place it at Schedule 1 in the first place. What a crock.
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