Two essential cannabis law questions for the next Attorney General

Sessions’ comment is a total non sequitur, a decoy. The AG is fully-empowered to take action to review the status of cannabis under federal law. Put the questions to him.

Senator Sessions’ comment that, I paraphrase (while assuming he was quoted correctly), if people want cannabis legal then they should get Congress to change the law perplexes me. Congress created a  mechanism within the Controlled Substances Act for changing the way federal law treats cannabis that is within the discretion of the Attorney General: holding an evidentiary hearing before a DEA Administrative Law Judge on the proper classification of cannabis under federal law.

There was an evidentiary hearing in 1988. (It took sixteen years of litigation to get to that point.)  The Drug Enforcement Administration has refused to hold another hearing since then. However, the DEA Administrator works for the Attorney General and presumably if the Attorney General thinks it’s a good idea to hold a hearing the DEA Administrator will make it happen.

Here is question 1: will the next AG hold a long-refused evidentiary hearing on the proper classification of cannabis under federal law and if not why not? Perhaps if the Attorney General thinks that Congress should make the decision whether to change the law he could assist Congress in its evaluations by holding an evidentiary hearing. Let’s get the evidence out into the open, no?

On to question 2.

In the alternative, the AG should direct the DEA to change its regulations about whether to hold a hearing

If the spirit is not moving the AG to hold that hearing, then the next level down is to pose the essential cannabis law question: “what degree of medical use, medical opinion and/or patient opinion should be deemed a ‘currently accepted medical use in treatment in the United States’ that  would justify a hearing”?

This question is important. In addition to the DEA deciding on its own to hold a hearing, ordinary citizens can also ask for an evidentiary hearing. That’s what is called a “rescheduling petition” – the type of petition the DEA has been denying since 1988, as discussed above. (I discussed at length the DEA’s legal theory for maintaining permanent cannabis prohibition after it denied the Americans for Safe Access petition in 2011 and after it denied the petitions by Rhode Island, Washington State and Registered Nurse Bryan Krumm this past August.) It has consistently refused to hold an evidentiary hearing about whether there is a “currently accepted medical use in treatment in the United States”  on the grounds that…there is no evidence of a currently accepted medical use in treatment in the United States. (How do you present evidence to the DEA if it won’t hold a hearing at which you can present the evidence? Hmm. That’s why I called my initial post on this subject Madmen Rule You.)

The DEA reaches this conclusion by requiring the results of the same type of study as the last phase of an FDA clinical trial before it will find that there is evidence of medical use- even though there is federal appellate caselaw holding that that standard is too restrictive. (Again, once the DEA sees evidence of a medical use in treatment in the US meeting that impossibly narrow standard, then it will hold a hearing as to whether there is a medical use in treatment in the US. You get the logic, right?)

However, the DEA could always just change its test. There is nothing in the Controlled Substances Act requiring a petitioner to show medical use before getting a hearing. Requiring the results of an FDA-style clinical trial is something the DEA invented and presumably can un-invent so that outside petitioners (if the AG doesn’t want to do it) can stand a chance of getting the DEA to hold a hearing.

If so, then here is question 2: will the AG review the DEA’s test for “currently accepted medical use in treatment in the US and determine whether it is anything than a for keeping cannabis prohibited forever – one that is not consistent with the Controlled Substances Act – and if not why not?

Sessions’ comment is a total non sequitur, a decoy. The AG is fully-empowered to take action to review the status of cannabis under federal law. Put the questions to him.

 

Vaporizing cannabis prohibition: the gateway theory is gone

 

The FDA and the DEA  abandoned the “gateway theory” in August 2016

gateway-to-hell
No turning back now. Should have just said no.

 

Newsflash: the “gateway theory” is no longer official government doctrine

There is much concern in the cannabis legalization movement/industry that the new administration will go to war against the legal cannabis markets. The nomination of Alabama Senator Jeff Sessions, recent comments by West Virginia Senator Joe Manchin that we need a “war on drugs” to fight the opioid crisis and that opioid abuse begins with youth experimentation with cannabis, and the reappearance of Reagan drug policy advisor Carlton Turner collectively indicate that we are heading into a time-warp rollback to Reagan/Bush-era prohibition. If so we can expect to see zero tolerance for cannabis (in the guise of “drug prevention”) reascend to its historic place as the cornerstone of national drug control policy.

The “gateway theory” or “steppingstone theory” that experimentation with cannabis inexorably leads to experimentation with and eventual dependence on other substances (opioids, for example, as we see in Senator Manchin’s comments) has been official government doctrine at least since the early 80’s when the “prevention” movement became the key constituency of the federal drug control agencies. (See Dan  Baum’s Smoke and Mirrors Chapters 5-6, 8 and 10 for an interesting treatment of the subject.)

On August 11, 2016, the DEA published two decisions each one denying a petition (one by the governors of Rhode Island and Washington State and the other by nurse Bryan Krumm) to hold evidentiary hearings on the proper classification of cannabis under federal law. There was much furor at the time expressed as amazement that the DEA could be so “out of touch” with public attitudes towards cannabis and so oblivious to the new scientific knowledge about cannabis – but, other than my December 19 blogpost, there was no attempt to understand the DEA’s reasoning in concluding that there is no basis even to hold evidentiary hearings.

Lost in the furor, however, was a noteworthy change in official position: the FDA’s report that is the basis for each of the DEA’s decisions states “Overall, research does not support a direct causal relationship between regular marijuana use and other illicit drug use.” See the Federal Register at 81 FR 53688, 53705. The report goes on to say that

First, in general, studies recruit individuals influenced by a myriad of social, biological, and economic factors that contribute to extensive drug abuse.

Second, most studies that test the hypothesis that marijuana use causes abuse of illicit drugs use the determinative measure any use of an illicit drug, rather than DSM-5 criteria for drug abuse or dependence on an illicit drug (DSM-5, 2013). Consequently, although an individual who used marijuana may try other illicit drugs, the individual may not regularly use drugs, or have a diagnosis of drug abuse or dependence. [Emphasis in original.]

Little evidence supports the hypothesis that initiation of marijuana use leads to an abuse disorder with other illicit substances….

Interestingly, the order of initiation of drug use seems to depend on the prevalence of use of each drug, which varies by country…. Specifically, in the countries with the lowest prevalence of marijuana use, use of other illicit drugs before marijuana was common. This sequence of initiation is less common in countries with higher prevalence of marijuana use….

Although many individuals with a drug abuse disorder may have used marijuana as one of their first illicit drugs, this fact does not correctly lead to the reverse inference that most individuals who used marijuana will inherently go on to try or become regular users of other illicit drugs….even if one posits that every cocaine and heroin user previously used marijuana, the [National Survey on Drug Use and Health] data show that marijuana use at least once in a lifetime does not predict that an individual will also use another illicit drug at least once.

 Finally, a review of the gateway hypothesis…notes that because the gateway hypothesis only addresses the order of drug use initiation, the gateway hypothesis does not specify any mechanistic connections between drug “stages” following exposure to marijuana and does not extend to the risks for addiction. This concept contrasts with the concept of a common liability to addiction that involves mechanisms and biobehavioral characteristics pertaining to the entire course of drug abuse risk and disorders.

In other words, the United States Government no longer espouses the position that cannabis leads inexorably to experimentation with and addiction to other drugs: the FDA and DEA tag-team just eliminated the major policy argument for maintaining permanent cannabis prohibition. Fascinating, no? The only thing perhaps more fascinating than this development is the fact that it received no attention.

The future into which we head, wherein the world order that has prevailed since 1945 is free-floating or perhaps free-falling, is beyond imagining – with one exception. We can be sure that the gateway theory will return in strength as the prohibitionists come out of hiding. (They never went away, they just went underground, except for Kevin Sabet, who has been keeping the fire alive for the anti-cannabis resistance.) When the proponents of zero tolerance identify cannabis legalization as the cause of the opioid crisis you are equipped to challenge them to explain how that theory works now that two of the most significant agencies in federal drug control have abandoned it.

Virtual reality and psychedelic prohibition

Gonzalez Franco predicted technology would allow users to experience mind-altering hallucinations that often occur under the influence of psychedelic drugs but without all the dismal side effects of taking a substance like LSD.

from an International Business Times article on a new product line from Microsoft.

Dismal side effects of taking a substance like LSD.
Like…a lower electric bill than you’d pay for VR?

Restated: why legalize psychedelics when you can just … plug into the matrix.

It will be ironic if virtual reality serves the same function to psychedelics as alcohol and prescription meds serve to cannabis – the ‘legal alternative’ that keeps the psychedelic competitor out of the market.

Vaporizing cannabis prohibition under Trump: make the DEA defer to state law

  • 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

 

Big Acid

The following video is relevant to people who advocate for psychedelic legalization.

Cannabis lawyer Hilary Bricken posits that (a) state-level regulatory factors have given rise to “Big Marijuana,” the for-profit industry that requires deep capitalization and therefore monopoly (functional or actual) and (b) the prohibitionist movement (which is not dead, just dormant waiting for the opportunity to reassert the control they traditionally exercised over the federal drug control agencies) has made “Big Marijuana” the centerpiece of their current position. (To their credit, the prohibitionists have evolved with the current national mood to a position more reasoned and sophisticated than “Just Say No.”)

I have always assumed that the supply side of a legal market for psychedelics will not be dominated by for-product interests.

Am I wrong? Are there self-limiting factors inherent to psychedelics that will necessarily avoid what Bricken posits, the type of commercialization required by a heavily-regulated supply side to keep consumption steady (if not increasing) in order to be make a profit?

If not, what happens if the supply of psychedelics in a legal market is subject to over-restrictive regulations, limiting the supply only to corporate interests that can obtain financing?  (I ask thinking especially of botanicals if over-harvesting in the natural environment requires cultivation in artificial conditions and thus high-tech expenses.) Will these corporate interests require promotion of psychedelics as part of a hip lifestyle in order to promote consumption? Will use in a legal market increase to the extent that people will simply need higher, deeper, farther experiences, thus shaping a different kind of industry? If yes, what, if any, are the public health consequences?

The only model I can see is one that, presumably through tax incentives, facilitates development of small, not-for profit membership organizations that have both (a) the ability to monitor use by individual members and (b) the ability either (1) to cultivate/manufacture their own ‘products’ [I use that term deliberately] or (2) the ability to purchase collectively from professional cultivators/manufactures, whether (i) domestic or (ii) foreign exporters.

Psychedelic prohibition as restraint-of-trade: results from a limited trial of psilocybin for treatment-resistant depression

The Imperial College of London just announced that a small safety trial of twelve patients with moderate to severe treatment-resistant depression shows that psilocybin can be administered safely and can relieve symptoms of depression for up to five months.

The article states that 350 million people around the world (that’s all?) suffer from depression. Other than safety the purpose of the study was to make an initial determination as to whether psilocybin could be an effective treatment for depression.

It has always seemed to me that if news spreads that psychedelics can be useful in treating depression and/or anxiety there will be heavy pressure on the floodgates considering the high number (so it seems to me) of people who experience those conditions. Perhaps the 350 million number is limited to people who are “clinically” depressed, as opposed to people who have depressive or anxious tendencies. Still 350 million people is a respectable consumer pool.

Preliminary findings that psychedelics, including but not limited to psilocybin, can affect those conditions positively highlight what I, as a commercial litigator, have always believed is the essence of psychedelic prohibition (including cannabis): psychedelic prohibition is a form of market-protection for businesses whose pharmacotherapy products simply suppress symptoms as opposed to facilitating changes in cognitive perspectives. In other words, psychedelic prohibition just prohibits competition in the market of treatments for “psychiatric disorders,” a restraint-of-trade that should be illegal – except that it is a creation of governments around the world. I can’t claim any great familiarity with the travails of the market for “alternative” energy, however it seems to me that there is an analogy: imagine if solar energy were criminally-prohibited.

 

"Medical marijuana" programs have few patients – and why is that?

The press release is the summary of a study authored by researchers at Columbia University:

Variation in medical marijuana program regulations impacts enrollment: A study published today in Health Affairs found that while 14 of the nation’s 24 medical marijuana programs were essentially nonmedical in practice, they enrolled more than 99 percent of overall participants. Fewer than one percent were enrolled in ‘medicalized’ programs that adhere to accepted professional standards in medicine. The study analyzed the extent to which medical marijuana laws and program regulations incorporate accepted medical practice, good pharmaceutical manufacturing practices as established by the FDA, and restrictions on controlled substances.

They conclude that the very low number of patients enrolled in states with “medicalized” programs means only that there are high numbers of “recreational” users who are ‘gaming’ the system [my term] in the states with “non-medicalized” programs:

“The extent to which states regulate their medical marijuana programs appears to have a striking impact on how many people actually use each program,” noted Mark Olfson, MD, professor of psychiatry at Columbia University Medical Center (CUMC) and senior author of the paper. “High enrollment rates in less regulated medical marijuana programs raise the possibility that these programs may inadvertently attract recreational users.”

“The new findings raise questions of why doctors are involved in non-medical programs in the first place,” added lead author Arthur Robin Williams, MD, MBE, a fellow in the Department of Psychiatry at CUMC. “Building on this study we will look for associations between more restrictive regulations and public safety – including rates of recreational marijuana use, diversion to adolescents, emergency department visits and drug treatment admissions.”

Based on the experience of New York, I will propose another hypothesis, which is that the unduly onerous “medicalized” programs are a cruel perversion of the original idea of state laws that were intended to facilitate access to cannabis by patients; instead the medicalized programs are intended to be or are operated as a means to deny access.