- Change federal drug law to require that the DEA consider whether states accept that there is a medical use for cannabis
Back in October of 2012 I published an explanation of the DEA’s legal justification for permanent cannabis prohibition and how to attack it. I explained that the DEA misconstrues the Controlled Substances Act (the “CSA”), the federal statute that governs cannabis, in order to stop any attempt to move cannabis out of Schedule I, the complete-prohibition category in the CSA. The first step in reevaluating the prohibition of cannabis is to hold a hearing in which a judge will hear testimony about its dangers and its benefits (if you can imagine such a thing). The DEA requires anyone seeking such a hearing to prove – before the hearing – that cannabis is “effective” for “medical use” – even though that’s what is supposed to be determined at the end of the hearing. There is no such requirement in the CSA. I explained that the DEA will not consider any evidence that cannabis is “effective” except the results of Phase III clinical trials, the clinical trials that the Food and Drug Administration requires when evaluating whether to approve a drug for marketing and sale, even though a federal appeals court has already said that the DEA must consider evidence other than whether the FDA has approved the substance.
More fundamentally, I explained that, instead, the DEA doesn’t even have Constitutional authority to do anything more than look at how states (and presumably the District of Columbia as well) treat cannabis under their laws. (I leave to others the question whether the ways that US territories and possessions regulate cannabis affect the evaluation.)
I titled the post “Madmen Rule You,” an expression of my conclusion that the public servants at the DEA are insanely- and ideologically-obsessed with keeping cannabis prohibited forever under all circumstances by any means necessary – including by deceptive legal sophistry, no matter what the citizens say and want and what the state governments do. I followed up with a more succinct explanation in January 2013 when I explained how a federal appeals court ruled that month on the DEA’s refusal to hear evidence concerning whether to move cannabis out of Schedule I.
Threat of counter-revolution under the new administration
In light of the recent election of Donald Trump as president and concern about what his administration might do to the cannabis markets operating legally in more than half of the states, I think it appropriate to explain again now the precise way that the DEA operates and to propose particular points of engagement that could open the door to moving cannabis down in the Schedules or even, if done properly, out of the Schedules altogether.
It may be that Trump will recognize that cannabis prohibition is a protectionist restraint of trade that criminalizes a commodity because it could disrupt the market and compete (too) effectively against numerous mega-industries and he -a friend of industry and entrepreneurship and of making America great again through job-creation – will accordingly direct his Attorney General to leave alone the markets in the states that have legalized cannabis for medical use or for general use.
On the other hand, it may be that while he is…distracted with other matters…the aggressive and reenergized prohibitionist forces (for-profit prison interests, drug-testing companies, law enforcement associations, abstinence-only moralists, and other constituencies) will take back control over federal drug policy, presumably with a warm welcome from the law-and-order types in the administration, and we will have an exponential version of the Reagan-Bush drug war, a dystopian nightmare of all-pervasive surveillance, massively massive mass incarceration, and coerced treatment.
In my assessment this is no time for passivity.
Proposal: amend the Controlled Substances Act to require that the DEA consider evidence of what is happening in states in which cannabis use if legal
Here is a plan of action: focus all legalization-positive legislators at all levels to demand an amendment to the CSA which will clarify that the rights of the states under the Tenth Amendment of the Constitution to determine the scope of the practice of medicine include determining that cannabis has medical benefits for their citizens. The consequence will be that whether there is a “currently accepted medical use in treatment in the United States,” the essential test in moving cannabis out of Schedule I, is determined by referring to state law – not, as the DEA insists, by considering only the results of a narrow (and extremely expensive) set of federally-regulated clinical trials that, in practice, will never happen for cannabis.
The issue is the same whether you are (a) trying to move cannabis to a lower Schedule or (b) you are trying to move it out of the Schedules altogether (and presumably out of the hands of the Department of Justice and into the jurisdiction of another Cabinet department, say Department of Health and Human Services, the Department of the Treasury, the Department of Agriculture, etc.). (Moving cannabis out of the schedules -“de-scheduling” – is the essence of legalization for “non-medical use” A/K/A “full legalization.”) If you can’t get a hearing as to whether there is a medical use of cannabis sufficient to move cannabis to a Schedule lower than Schedule I then you are not going to get a hearing as to whether to move cannabis out of the Schedules entirely.
If you want to legalize cannabis at the federal level I suggest you take a moment to consider the analysis below (and, if you want the specifics, the 2012 and 2013 posts also).
If you disagree tell me why. If I agree with you I’ll work with you to devise another plan.
If you agree then let’s go.
The essential question is what evidence the DEA will consider
Whether a psychoactive substance can move out of Schedule I is determined in an “evidentiary hearing” in which witnesses testify and present evidence to an administrative law judge. Whether to hold such a hearing depends on what evidence the DEA will consider because under the CSA the DEA has the option of refusing to hold a hearing (which is exactly what it has done since 1994). The DEA’s position is that in order to hold such a hearing it must be shown the results of large-scale clinical trials of the type that the FDA requires in order to approve a drug for marketing demonstrate “efficacy” of the substance for some purpose.
What that means in practice is that all other evidence – technically “anecdotal evidence” in the world of cannabis rescheduling – is irrelevant. Testimony of parents that cannabis saved the lives of their children – irrelevant. Conclusions by physicians based on first-hand observations that their patients have improved after using cannabis – irrelevant. Published peer-reviewed articles in medical journals describing positive effects of cannabis – irrelevant. Statistical evidence showing that people move away from opioids to cannabis when it’s legally available – irrelevant. Everything other than the results of clinical trials is irrelevant – and those must be randomized double-blind trials, the final clinical trials the FDA requires before deciding whether to approve a drug for marketing and sale. They are huge trials with hundreds if not thousands of test subjects; there are different sets of test-subjects, one receiving the test substance and one or more control groups receiving a placebo, and neither the test subjects nor the test-givers know who is getting what. There is no basis in the CSA for such a test. The DEA made it up on its own.
The DEA’s theory
- The elements of “Schedule I”
Technically, it works like this:
First, there are three criteria for a psychoactive substance to be in Schedule I: “(A) The drug or other substance has a high potential for abuse, (B) The drug or other substance has no currently accepted medical use in treatment in the United States, and (C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.” We are concerned with (B) because everything turns on it as United States Court of Appeals for the District of Columbia Circuit recently held in the Americans for Safe Access v. Drug Enforcement Administration proceeding. (In that decision the appeals court said that the existence of such “medical use” is the threshold question: if you fail to meet that test there is no reason to consider anything else.)
Second, the CSA sets out eight factors that the DEA must consider when presented with a petition to hold a hearing as to whether to move a substance around in or out of the Schedules. None of the factors require any proof of “efficacy.”* However, the DEA construes the third factor – “The state of current scientific knowledge regarding the drug or other substance” – to mean proof of efficacy. An impossible stretch? Absence of logic? I think so. But that’s the twisted logic of cannabis prohibition.
Third, the DEA uses a five-factor** test to determine whether a substance has a currently accepted medical use in treatment in the US, the third factor of which is “There must be adequate and well-controlled studies proving efficacy.” The DEA construes this phrase – its own invention – to mean the results of Phase III clinical trials.
- What is a “currently accepted medical use in treatment in the United States”?
The requirement of the results of a Phase III clinical trial is a clever way the DEA escapes the result of a federal appeals court ruling in the 1987 decision of Grinspoon v. Drug Enforcement Administration in the United States Court of Appeals for the First Circuit. Dr. Lester Grinspoon challenged the DEA’s placement of MDMA in Schedule I. The DEA said at that time that a “currently accepted medical use in treatment in the United States” could only mean that the FDA had approved the drug for marketing and sale. The appellate court disagreed: it said that FDA approval could be proof of such a medical use but it was not the only possible proof. In response the DEA formulated the five-factor test with the requirement of “adequate and well-controlled studies proving efficacy” described above – which it defines as being the Phase III clinical trials that are the last step before approving for FDA approval. In other words the DEA defined “the adequate and well-controlled studies proving efficacy” that must be shown before there can be a hearing on rescheduling as the type of huge and hugely expensive clinical trials that in practical reality no one in their right mind would do except in the course of applying for FDA approval. The DEA’s test is, in effect, exactly the same test that the federal court rejected in the Grinspoon decision.
The DEA has no Constitutional basis for doing anything other than checking to see what the states are doing
Finally, I demonstrated in Madmen Rule You that the DEA’s position is unconstitutional. The United States Supreme Court held in the decision of Gonzalez v. Oregon (see the discussion of Gonzales in Points X-XI of Madmen Rule You) that the United States Attorney General has no ability to define the scope of the legitimate practice of medicine (which he attempted to do in threatening the registration of physicians who participated in assisting patients with terminating their own lives under Oregon state law) since the scope of the practice of medicine is determined under state law. Under that reasoning the question of whether there is a “currently accepted medical use in treatment in the United States” for cannabis must as a Constitutional matter be determined by looking to how individual states treat cannabis. If there is state law recognizing therapeutic uses of cannabis then it’s game over: there is a currently accepted medical in treatment in the United States. Although the District of Columbia and state court decisions from 1975 to 1996 that recognized a common law “medical necessity” defense for cannabis use should be sufficient, the existence of state statutes finishes off the question in favor of the inescapable conclusion that there are numerous uses of cannabis that are currently accepted by state governments as medical (or at a minimum “therapeutic”) even though the FDA has not issued approval under federal law to market the substance and sell it in interstate commerce.
What is to be done
The fact that the DEA has set its test for medical use so impossibly narrow and refuses to consider any evidence other than the results of a Phase III clinical trial is perhaps the least-understood but most critical aspect of federal cannabis prohibition. After the DEA denied the two most recent attempts to get an evidentiary hearing(the most recent denial in August of this year), the press ran story after story saying that the DEA had decided that cannabis has no medical use. No – speaking precisely, the DEA decided that there have been no massive clinical trials the results of which justify holding a hearing to hear testimony about whether there’s a medical use of cannabis. Since no one in the press ever asked what evidence the DEA considered or didn’t consider in denying the petitions they never realized that the DEA refuses to consider anything as evidence except what is impossible in practice to obtain.
In essence, all prior attempts to move cannabis out of Schedule I have attempted to show that cannabis meets the DEA’s test for rescheduling. That approach is a mistake. The proper approach is to show that the DEA’s test is wrong.
Now you know. I have explained that the way that the DEA maintains permanent prohibition is by fabricating a requirement that a petitioner seeking to set in motion the only process that can result in moving cannabis down or out of the Schedules show the results of FDA Phase III clinical trials. I have explained that the DEA has no authority to define what is a currently-accepted medical use in treatment in the United States. That is a matter that should be determined by looking at state law.
If so then it is time to make, at a minimum, one small amendment to the CSA: amend the statutory definition of “currently accepted medical use in treatment in the United States” to include reference to state law. For example, change the language to read “a currently accepted medical use in treatment in the United States, the existence of which shall be determined with regard for state laws concerning the substance” or “a currently accepted medical use in treatment in the United States, the existence of which shall be deemed established if there is a state law authorizing use of the substance for medical purposes.” Et cetera.
Another way is to clarify that the eight factors the DEA must consider in deciding whether to hold the hearing do not require a showing of efficacy. Factor three could be changed to read “The state of current scientific knowledge regarding the drug or other substance; this factor shall not require evidence of efficacy.” Presumably that would require the DEA to reformulate its test and there would be no more rule that could require a petitioner for an evidentiary hearing show the results of “adequate and well-controlled studies proving efficacy” – or any proof of efficacy. Good-bye requirement to show the results of the functional equivalent of a Phase III clinical trial and anything like it.
Do I believe that it will be easy to convince a Republican Congress to pass legislation amending the CSA to make it easier to hold an evidentiary hearing on the proper classification of cannabis? No, but it’s an approach based on giving more power to the states, i.e. more power to the people at the local level, and that principle has some traction in multiple constituencies other than cannabis law liberalization supporters. The voters in the majority of the states have already said what they want.
If Obama doesn’t reschedule cannabis before he leaves office is there another choice?
*Here are the eight factors that the DEA must consider in deciding whether to hear witness testimony:
(1) the drug’s actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
** Here is the five-factor test the DEA created in 1994 to test for the existence of a “currently accepted medical use in treatment in the United States”:
i. The drug’s chemistry must be known and reproducible
ii. There must be adequate safety studies
iii. There must be adequate and well-controlled studies proving efficacy
iv. The drug must be accepted by qualified experts
v. The scientific evidence must be widely available