Commentary: Clearing The Smoke on Medical Marijuana, Part I
Medical marijuana is a source of confusion, frustration and ignorance among many of us. On the one hand, we don’t want to see our loved ones suffer from needless pain, yet on the other hand, as professionals in the substance abuse field, we want to see all medications depoliticized and subject to the proper scientific process.
Much to the ire of legalization advocates – who banked on President Obama looking the other way while states voted to make an illegal drug medicine – the feds, working with state officials, have expanded its enforcement actions against commercialized “medical marijuana” operations. These operations market to kids, are tied to criminal organizations and their customers bear little resemblance to the truly sick and dying. There is no doubt that medical marijuana is a controversial and complex issue. I try to break down several of the more complicated issues, once and for all, in this two-part series.
In the wake of recent enforcement, the governors of Washington, Rhode Island and Colorado have filed a petition with the Drug Enforcement Administration (DEA) to reschedule marijuana1. Specifically, the petition asks the DEA to reclassify marijuana from Schedule I to Schedule II of the federal Controlled Substances Act (CSA). The governors contend that such rescheduling will eliminate the conflict between state and federal law and enable states to establish a “regulated and safe system to supply legitimate patients who may need medical cannabis.”
Unfortunately, rescheduling, besides being an ill-advised move for several reasons, would not even solve the governors’ states’ problems. Under the CSA, a substance is scheduled into one of five classes – Schedule I means that it has no medical use, and high potential for abuse. The primary difference between Schedule I and II substances lies in the phrase “currently accepted medical use in the U.S.” This phrase has been interpreted to require that the drug’s chemistry is known and reproducible, that there are adequate studies on safety and efficacy, and that the drug must be accepted by qualified experts and backed up by widely available peer-reviewed science2 (mere anecdotal evidence, state laws or even the policy positions of medical organizations, are not sufficient to satisfy these criteria). But placing marijuana in Schedule II alone, even if it were to pass that rigorous test, is not enough to get the governors out of their conundrum.
The big point is this: Schedule II substances may be prescribed by physicians and dispensed by pharmacists only when incorporated into specific FDA-approved products. This fact is sometimes articulated as follows: “Schedule II substances may be prescribed.” This abbreviated description, however, is dangerously incomplete and, as a result, has caused significant confusion. Such confusion underlies the governors’ current petition.
The FDA approves specific medical products produced by a particular “innovator” (for branded products) or generic manufacturers. For example, oxycodone, an opioid, is in Schedule II. Specific products, such as OxyContin® (an extended release form), are also in Schedule II. Physicians prescribe a specific branded or generic product, in a particular dose and dosage form. Smoked marijuana can’t be prescribed because there is no standardized dose and no specific product.
Imagine for a moment that the “medical marijuana” advocates were instead “medical opium” advocates and that various states passed laws legalizing the cultivation and distribution of opium plant material, i.e., opium latex or poppy straw. Even though opium latex and poppy straw are each in Schedule II, there would still be a conflict between such state laws and federal law. As a well-known drug reform advocacy website states: “If poppies are grown as sources for opiates, there is no question that it violates the CSA.”3 Furthermore, physicians would not be authorized to prescribe, nor pharmacists to dispense, dried opium or poppy straw. In order to be prescribed, a specific product containing opiate active ingredients (APIs) would have to pass muster in the FDA approval process. Therefore, the mere act of placing herbal marijuana in Schedule II would not make it available to patients nor address the conflict between state and federal law.
The governors’ petition asserts that there is a “consensus of medical opinion concerning medical acceptability of cannabis amongst the largest groups of physicians in the United States.” Additionally, a committee of the California Medical Association recently called for the rescheduling of marijuana “so it can be tested and regulated.” In Part II, I will tackle these issues and more.
Kevin A. Sabet, PhD, Policy Consultant and Assistant Professor, University of Florida, College of Medicine, Division of Addiction Medicine, Department of Psychiatry. To read more from Dr. Sabet, visit www.kevinsabet.com or follow him on Twitter @kevinsabet.
1 Ingold, J. (Dec. 29, 2011) “Colorado Asks DEA To Reschedule Marijuana.” Denver Post Accessed on January 20, 2012 at http://www.denverpost.com/news/marijuana/ci_19636149
2 See Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C.Cir. 1994); 57 F.R. 10499, 10506, 10507.