The medical marijuana community was disappointed to learn the nation’s top drug law enforcement agency — the Drug Enforcement Agency (DEA) — decided against keeping cannabis a Schedule I drug (a schedule reserved for the “most dangerous drugs” that have no “accepted medical use’ — like heroin), to a lower schedule, like Schedule II (“high potential for abuse,” but an “accepted medical use). Schedule II drugs, like cocaine and methamphetamine, while also considered dangerous and addictive, based on federally defined criteria, apparently have “accepted medical use.”
The DEA’s decision seems to defy common sense — not to mention, science — but the reason behind their decision is the ever-evolving definition of what constitutes “accepted medical use,” a bar that seems to get perpetually higher, the closer cannabis seems poised to qualify for rescheduling. By “accepted medical use,” the DEA — along with the Food and Drug Administration (FDA) and Health and Human Services — require that before any drug be transferred to a lower schedule, it must pass an impossibly subjective “8-Factor Analysis.” Further complicating the issue, a component of this analysis, is yet another subjectively defined, “5-Criteria Analysis,” designed to assess “accepted medical use.”
What constitutes the “5-Criteria Analysis,” you say?
- Criteria 1: The drug's chemistry is known and reproducible;
- Criteria 2: There are adequate safety studies;
- Criteria 3: There are adequate and well-controlled studies proving efficacy;
- Criteria 4:The drug is accepted by qualified experts;
- Criteria 5: The scientific evidence is widely available.
To acknowledge that cannabis has “accepted medical use,” it seems the two biggest issues the feds have, are Criteria 1 & 3.
With relative ease, anyone knowledgeable in basic chemistry and skilled in cannabis horticulture, can easily identify the basic chemical composition of any cannabis strain. And, of course, it’s easily reproducible. Cloning anyone?
However, their argument — as silly as it may seem — is that while this may be true, in practice, the cannabis one finds at dispensaries can vary greatly in chemical composition (High THC/Low CBD; High CBD/Low THC; 1:1 ratios; etc.) However, this is a poor excuse, as there are other botanicals that appear on lower schedules. (Half a dozen “poppy flower” preparations appear on Schedule II.) Moreover, by simply establishing acceptable standard therapeutic ranges would address this issue. However, that could also open a big can of worms, opening up an unwelcome expansion of FDA oversight.
The feds issue with Criteria 3 is one that causes me considerable consternation. By “adequate and well-controlled studies proving efficacy,” they mean “gold standard” randomized-controlled trials (RCTs). RCTs are FDA-approved studies that drugs go through when applying to become FDA-approved drugs. Well, it should be no surprise that none of these exist. The reason being: Federal policy makes Schedule I drugs the most difficult to study. (The first study of botanical cannabis — MAPS Foundation and Dr. Sue Sisley’s PTSD study — took nearly seven years to work through the system.) Worse, there have long been two additional bureaucratic hurdles unique to cannabis — oddly, they don’t apply to other Schedule I drugs like heroin, LSD, or MDMA:
Obstacle 1: Public Health Service (PHS) Review
First, cannabis had to pass a special “public health service” (PHS) review, which could literally take years to go through.
Reporting on the Americans for Safe Access website, Dr. Sue Sisley, commented: "The US government has systematically impeded marijuana efficacy research, and the PHS review has played a large role in that stonewalling." Sisley continued, "It was a shameful tactic used by opponents of marijuana research who never wanted the public to see objective data about the efficacy of marijuana. To see the government finally eliminate this waste of taxpayer dollars is a triumph and hopefully represents another historic shift in drug policy reform."
Obstacle 2: The Federal Government’s Monopoly on Research-Grade Cannabis
Second, for half a century the government has operated a production monopoly on the cultivation of cannabis for research purposes. Just one source — the University of Mississippi — could supply cannabis for research purposes.
Researchers long complained (unsurprisingly) that cannabis coming from a sole governmentally controlled source was of inferior quality and lacked diversity of strains (of variable chemical composition). Ole’ Miss only recently began growing high CBD strains, for example. Moreover, the highest THC available is 12%. Want to compare strains — say a Landrace strain to Purple Arrow? Out of luck! Moreover, researchers had to jump through an unreasonable number of hoops to acquire product — and, suffer unreasonably long wait times to receive their research materials.
Given how federal policy has impeded the sort of rigorous high-quality scientific research that involves humans (rather than lab rats), it should be no surprise, we lack the sort of “gold standard” studies the feds require to reschedule cannabis.
However, there is some good news: the government has finally — at least — acquiesced on these two points. Last year (on June 22, 2015), they removed the PHS review requirement. And, with their latest announcement, they’ve committed to removing another major research barrier: the monopoly.
While clearly very few people believe cannabis deserves to be classified alongside heroin as a Schedule I drug — over at least the short-term — how much does it really matter?
Probably, not much. The DEA was never going to reschedule cannabis from Schedule I to Schedule III, which would have opened up banking, and in and of itself, vastly expanded research. However, a transfer to Schedule II would have had a nominal effect. The feds are already following — more or less — a policy of non-enforcement against states with medical marijuana laws. Of course, that could change with a hostile new administration.
But, for the time being, we can find some relief from the fact we’ve successfully convinced the feds to remove two major barriers to research. But, of course, this is a bandaid solution, and long-term reform is needed. But, as long as we allow a nonsensical, inconsistently applied, often hypocritical scheduling system to continue to exist, progress will be slow and unsatisfactory: Consider how absurd a scheduling system is that ...
- Classifies cannabis with heroin equally
- Places various (highly toxic and addictive) opioid preparations on four out of five schedules
- Places pure synthetic THC (Marinol) on Schedule III — lacking the temperance of CBD, pure THC is far more psychoactive and side-effect inducing than botanical cannabis
- Does not schedule alcohol or tobacco — both of which are more addictive and deadly than cannabis, and have NO “accepted medical use”
- Classifies Xanax, Soma, Klonopin, and Valium, as Schedule IV drugs (low potential for abuse), drugs involved in one out of three fatal drug overdoses
- Considers LSD precursor and hallucinogen, LSA, a Schedule III drug
- Literally lists “Crack,” “Ice,” “Meth,” “Crank” and “Speed” as Schedule II drugs
Likewise, the policy ignores data proving that states that enact medical marijuana laws experience significant public health benefits:
- Alcohol abuse and traffic fatalities drop in MJ states
- Suicide rates drop after states enact medical marijuana laws: Among 20 - 29 year old males, suicides drop 11 percent; among 30 to 39 years, 9% fewer people kill themselves.
- Opioid-related fatal drug overdoses drop 25% in states with medical marijuana laws
Clearly, the current system is broken. It’s irresponsible to ignore the benefits of expanding access to cannabis. Maintaining the status quo is a morally indefensible position. But, until we acknowledge the facts, recognize the science, and revamp what is a fundamentally broken system, how much progress can we really make?
As I argue in my forthcoming book, Schedule ZERO: The Case for Rethinking Cannabis and Our Broken Scheduling System, it’s high time (and long overdue) that we finally question our ill-conceived scheduling scheme that was devised not based on advancing scientific progress or putting the interests of patients first, but was driven by political agenda. And, until we acknowledge these facts, and make substantive changes, it will be the patients who continue to needlessly suffer.
(Guest blog by Jeremy Kossen, author of forthcoming book, “Schedule ZERO: The Case for Rethinking Cannabis and Our Broken Scheduling System”)