Forbes investigates the laws and politics surrounding marijuana, noting how medical marijuana research is being blocked by federal agencies. The article highlights President Obama’s recent comments about the safety of marijuana, and MAPS Founder Rick Doblin explains that receiving further research approval is necessary for marijuana to become reclassified. “Assuming that marijuana has been approved as a prescription medicine by the FDA,” Doblin says, “Schedule II seems too high, since Marinol is in Schedule III. Due to its actual abuse potential, marijuana for medical use should be in Schedule V.”
Originally appearing here.
Ever since Congress passed the Controlled Substances Act (CSA) in 1970, drug policy reformers have complained that marijuana does not belong on Schedule I, the statute’s most restrictive drug category. Schedule I ostensibly is reserved for drugs with a “high potential for abuse” that have “no currently accepted medical use” and are so dangerous that they cannot be used safely, even under medical supervision. It is highly debatable, to say the least, that marijuana meets any of those criteria, let alone all three. But over the years, most recently in 2011, the Drug Enforcement Administration (DEA) has repeatedly rejected petitions asking it to take marijuana off Schedule I, where it sits alongside heroin and LSD, above supposedly safer drugs such as cocaine, morphine, and methamphetamine.
In light of President Obama’s recent observation that marijuana is safer than alcohol, CNN’s Jake Tapper wondered if he was open to reconsidering marijuana’s status as a Schedule I drug. When Tapper asked him that in an interview that aired last week, Obama derailed the conversation by denying that the executive branch has the power to reclassify marijuana. That clearly is not true, since the CSA gives the attorney general the authority to move drugs between schedules. The attorney general has delegated that authority to the DEA (a division of the Justice Department), which is why that agency has been the recipient of petitions urging it to put marijuana in a less restrictive category.
Because Obama incorrectly insisted that rescheduling marijuana would require an act of Congress, he never addressed the merits of doing it administratively. From the perspective of people who believe marijuana should be legalized for medical or general use, the advantages of such a move are not as substantial as you might think. But neither are they, as UCLA drug policy expert Mark Kleiman claims, “identically zero.” Moving marijuana to a less restrictive legal category would have some significant practical effects, perhaps the most important of which would be to advance a more honest discussion of marijuana’s hazards and benefits.
As Kleiman points out, removing marijuana from Schedule I would not automatically make it legal for medical use, since any cannabis product still would have to be approved by the Food and Drug Administration (FDA). “For a doctor to prescribe it,” notes Aaron Houston, a Marijuana Majority board member and WeedMaps lobbyist, “there would have to be an FDA-approved formulation of it.”
Since marijuana itself cannot be patented, a pharmaceutical company would not have much incentive to go through the arduous, time-consuming, and expensive process required to gain FDA approval. Furthermore, drug regulators tend to look askance at herbal medicine, preferring isolated chemicals. “They’re never going to approve a whole-plant organic product,” says Dan Riffle, director of federal policies at the Marijuana Policy Project.
But Riffle adds that rescheduling marijuana would make it easier to conduct research on the plant’s medical utility, which could lead to cannabis-derived medications that would pass muster with the FDA. “The biggest obstacle, at least historically, to doing research on marijuana to prove its medical benefit is that it’s in Schedule I,” Riffle says. “So you had that Catch-22, where marijuana is a Schedule I drug because there’s no evidence, and there’s no evidence because marijuana is a Schedule I drug.”
Harvard psychiatrist Lester Grinspoon, co-author of Marihuana: The Forbidden Medicine and a leading expert on cannabis, agrees that marijuana’s Schedule I status has impeded research. “Since 1970,” he says, “it has been the major reason why the kinds of large double-blind studies which have been the basis for FDA approval of medicines since the mid-1960s have been impossible to pursue in this country.” Dale Gieringer, who runs the California chapter of the National Organization for the Reform of Marijuana Laws, notes that “there are very burdensome registration requirements and regulations regarding Schedule I substances.” Although “most of them also apply to Schedule II,” he says, they do not apply to substances in Schedules III through V, which are deemed to have progressively lower potential for abuse.
There are other research obstacles, unique to marijuana. In 1998, responding to the legalization of medical marijuana in California, the Clinton administration imposed an additional layer of review on research involving cannabis, requiring approval by the Public Health Service as well as the FDA, the DEA, and the relevant institutional review board. And even after they get all the other necessary approvals, researchers have to obtain marijuana from the National Institute on Drug Abuse (NIDA), which has a monopoly on the legal supply—something that is not true of other Schedule I drugs. NIDA, an agency whose mission focuses on marijuana’s hazards, has not been keen to assist research aimed at measuring its benefits. Although neither of these requirements is a necessary consequence of marijuana’s Schedule I status, they would be harder to defend if marijuana were reclassified, which would mean acknowledging that it has medical value and can be used safely.
Rescheduling marijuana would not affect the legal status of state-licensed cannabusinesses in states such as Colorado and Washington, which would still be criminal enterprises in the eyes of the federal government. But Gieringer notes that rescheduling could remove one of the major financial challenges facing state-legal marijuana suppliers: Section 280E of the Internal Revenue Code prohibits the deduction of business expenses related to “trafficking in controlled substances,” but only for drugs on Schedule I or II. If marijuana were moved to, say, Schedule III, that prohibition would no longer apply.
Schedule III, which is supposed to be for medically useful drugs that can be taken safely and have a lower abuse potential than drugs on Schedules I and II, arguably is appropriate for marijuana because that is where the DEA put Marinol (a.k.a. dronabinol), a synthetic version of THC, marijuana’s main active ingredient. The DEA also has said naturally occurring THC used in generic versions of Marinol belongs on Schedule III.
But depending on how you define abuse potential, marijuana could go on a lower schedule. “When you look at the Schedule IV drugs,” says SUNY at Albany psychologist Mitch Earleywine, author of Understanding Marijuana, “you’ve got the opiate Tramadol, the stimulant Modafinil, lethal sedatives like phenobarbital and chloral hydrate, and the ‘date rape’ drug rohypnol. Surely cannabis is safer than these.”
Grinspoon believes “none of the schedules is truly appropriate for marijuana.” But if it he had to pick, he says, “based on a realistic appraisal of the drug, I would put it in Schedule V.” That category, which includes codeine and opium preparations, is for prescription drugs with the lowest abuse potential.
Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, which for years
has been trying to jump through the hoops required to get marijuana approved as a medicine, notes that the DEA could move cannabis to a lower schedule only if it changed its definition of “currently accepted medical use,” which demands the sort of large-scale, multi-site, double-blind studies that the FDA requires to approve a new drug. “Assuming that marijuana has been approved as a prescription medicine by the FDA,” Doblin says, “Schedule II seems too high, since Marinol is in Schedule III. Due to its actual abuse potential, marijuana for medical use should be in Schedule V.”
Alex Kreit, a professor at Thomas Jefferson School of Law in San Diego who studies drug policy, notes that the CSA leaves undefined phrases on which scheduling hinges. The DEA therefore “has enjoyed incredibly broad discretion to interpret and define ‘potential for abuse’ and other scheduling criteria,” Kreit writes on the Marijuana Law, Policy & Reform blog. Just as it could adopt a less demanding definition of “accepted medical use,” the DEA could take a narrower view of “abuse,” which it equates with any nonmedical use. By that standard, marijuana, by far the most popular illegal drug, does indeed have a high potential for abuse. But that judgment seems peculiar if abuse is defined as problematic use, in which case potential for abuse might be measured by the percentage of users who become addicted or suffer serious harm.
In truth, as Lester Grinspoon observes, marijuana does not fit any of the schedules very well. It is not the sort of medicine the FDA is used to approving. But it clearly can be used safely, as Obama conceded when he noted that it is less dangerous than alcohol. Back in 1988, when he urged the DEA to reschedule marijuana, Administrative Law Judge Francis Young called it “one of the safest therapeutically active substances known to man.” And while marijuana surely can be abused (what can’t?), its potential for abuse seems lower than that of many pharmaceuticals, not to mention alcohol and tobacco, which the CSA specifically excludes from its schedules.
In light of these inconsistencies, could the DEA take marijuana off of the CSA’s schedules altogether? Probably not. “I think it is very unlikely that the attorney general could remove marijuana from the schedules entirely,” Kreit says. Although the CSA gives the attorney general the power to “remove a drug or other substance entirely from the schedules,” it also says that “if control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate.”
Since the 1961 Single Convention on Narcotic Drugs requires its signatories (which include the United States) to criminalize production, possession, and distribution of cannabis for nonmedical purposes, this reference to treaty obligations seems to bar the DEA from descheduling, as opposed to rescheduling, marijuana. Cannabis “requires a lot of control” under the Single Convention, notes Eric Sterling, president of the Criminal Justice Policy Foundation, who helped write federal drug legislation in the 1980s as counsel to the House Judiciary Committee. “Cannabis is supposed to be controlled like opium and opiates.”
Then again, Kreit notes, other CSA provisions “seem to contemplate situations where the U.S. does not accept international scheduling determinations.” Riffle, who is also a lawyer, sums it up this way: “I could make some arguments in a court that [the reference to drug treaties] doesn’t bind the executive, but I’d probably lose.”
The consequences of administratively descheduling marijuana are difficult to tease out, given that some provisions of federal law refer to marijuana specifically, while others talk about “controlled substances” or drugs on certain schedules. Aaron Houston notes one salutary result of descheduling marijuana: Its consumers would no longer be barred from owning firearms under the Gun Control Act of 1968, which purports to carve out an exception to the Second Amendment for “unlawful user[s] of…any controlled substance.”
Even if the CSA permitted the Obama administration to deschedule marijuana, such a step would be politically inconceivable. But even moving marijuana down one level, from Schedule I to Schedule II, could have an important impact on the drug policy debate. For one thing, it would free the Office of National Drug Control Policy (ONDCP), which is required by law to oppose the legalization of any Schedule I substance, to talk about the hazards of marijuana a little more honestly. Such freedom is desperately needed, to judge by the effort required to extract the concession that marijuana is safer than alcohol from ONDCP Deputy Director Michael Botticelli at a congressional hearing this week.
“You have Obama saying that marijuana is less harmful than alcohol, that it’s important for Colorado and Washington to move forward,” says Riffle, “but nonetheless you have the ONDCP saying, ‘We remain steadfastly opposed to legalization.’ If it weren’t a Schedule I drug, they wouldn’t have to say that. The ONDCP would be free to take a new position on legalization or put out more honest statements about the harms associated with marijuana.”
Rescheduling marijuana also might affect the level of cannabis candor at the Department of Health and Human Services (HHS), which is barred from using any of its funds to promote the legalization of Schedule I substances. Riffle thinks lifting that restriction might even make NIDA, which is part of HHS, more willing to let researchers use its marijuana.
Beyond such statutory implications, acknowledging that marijuana is more beneficial and less hazardous than the government has been saying all these years is apt to influence the conversation about how to handle this much-maligned plant. When the president conceded, in an interview with The New Yorker, that alcohol is more dangerous than marijuana, it set off weeks of high-profile discussion about whether pot prohibition is sensible or fair. If he followed up on that observation by asking whether marijuana meets the criteria for Schedule I, it would call further attention to the arbitrary distinctions drawn by our drug laws.
The resulting discussion could help pave the way for more ambitious moves, such as legislation lifting the federal ban on marijuana in the 20 states that have legalized it for medical or recreational use. Bill Piper, director of national affairs at the Drug Policy Alliance, says rescheduling is not his top priority, but it would be “a significant victory for commonsense drug policy,” because it “would acknowledge the weight of scientific evidence and popular support for medical marijuana, and it could boost state legislative efforts.”
Sterling thinks that acknowledgment could help people who get into legal trouble for growing medical marijuana. “Moving marijuana to any other schedule would be a recognition by the government that it has medical value,” he says, which “makes a difference in terms of what can be said to a jury.” Gieringer agrees. “Rescheduling would send a powerful message around the U.S. that marijuana does have medical uses,” he says, “even in states like Alabama that don’t allow it. This would help put to rest the common argument of cops and DAs that marijuana isn’t medicine.”
Regardless of the practical consequences, there is something to be said for telling the truth. “When Obama took office,” Riffle notes, “he said that decisions in his administration would be guided by science, not by politics and ideology. It’s very clear that marijuana’s continued classification as a Schedule I drug violates that mandate.”
Since Congress banned marijuana in 1937, says Houston, “we have seen extremely cynical efforts to overblow the danger of marijuana and to demonize it. A move to reschedule or unsch
edule would be the first time since 1937 that our government started to roll back some of that reefer madness.”