Marijuana's Mystifying Misclassification
A logic-defying law lets the DEA keep cannabis in a more restrictive category than morphine, cocaine, PCP, and methamphetamine.
On August 11, when the Drug Enforcement Administration (DEA) rejected two petitions asking it to reclassify marijuana, Fox News anchor Shepard Smith did not try to conceal his contempt. "LSD, MDMA, a plant that grows in the yard—all one thing," he said sarcastically. "The DEA announced today it will keep marijuana on the list of the most dangerous drugs in all the world, along with heroin, LSD, and MDMA….Thanks, DEA, you've really got a lot of credibility."
Smith's dismay was echoed by activists, scientists, commentators, and members of Congress from both major parties, who said the DEA's decision was at odds with what we know about marijuana's hazards and benefits. There is a lot of truth to that critique, and the DEA can reasonably be faulted for stubbornly refusing to remove marijuana from Schedule I of the Controlled Substances Act (CSA), a category that is supposedly reserved for drugs with "a high potential for abuse," "no currently accepted medical use," and "a lack of accepted safety for use…under medical supervision."
But bureaucratic intransigence is only part of the story. The other part is the CSA itself, a legal morass that leaves crucial phrases undefined, gives the DEA wide discretion to decide where drugs belong, and establishes arbitrary, inconsistent rules that make it impossible to properly classify many drugs.
Since Schedule I is the CSA's most restrictive category, people tend to assume it's supposed to be a list of "the most dangerous drugs in all the world," as Shepard Smith put it. But Chuck Rosenberg, the DEA's acting administrator, says that's a misleading way of describing Schedule I. In fact, he says, the decision to keep marijuana in that category did not involve an assessment of its relative hazards. While the DEA's determination that marijuana belongs in Schedule I was widely interpreted to mean it thinks marijuana is about as dangerous as other drugs in that category and more dangerous than drugs in lower schedules, the head of the DEA insists that is not what the decision means.
"Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous (including marijuana, which is less dangerous than some substances in other schedules)," Rosenberg writes in an August 11 letter to Rhode Island Gov. Gina Raimondo and Washington Gov. Jay Inslee, whose predecessors filed one of the rescheduling petitions that the DEA rejected this month. "That strikes some people as odd, but the criteria [sic] for inclusion in Schedule I is not relative danger….It is best not to think of drug scheduling as an escalating 'danger' scale—rather, specific statutory criteria (based on medical and scientific evidence) determine into which schedule a substance is placed."
Rosenberg's concession that marijuana "is less dangerous than some substances in other schedules" stands in stark contrast with his predecessor's refusal to say whether heroin is more dangerous than marijuana. A year ago, Rosenberg admitted that "heroin is clearly more dangerous than marijuana," and now he is taking the further step of saying some drugs in lower schedules are also more dangerous. But he argues that such observations do not mean marijuana should be reclassified.
According to the DEA's official explanation of its decision, the only factor that mattered was whether marijuana has a "currently accepted medical use." The agency says meeting that criterion requires the sort of large, expensive clinical studies that the Food and Drug Administration (FDA) demands before approving a new medicine. While such studies have been conducted with marijuana's main active ingredient (which is how Marinol, a capsule containing synthetic THC, was approved by the FDA in 1985) and are under way with Sativex, an oral cannabis extract spray, they have not been conducted with the whole plant. So unless the DEA was willing to reconsider its longstanding, court-approved definition of "currently accepted medical use," it was inevitable that it would once again say no to rescheduling.
Why does the DEA say medical use is the only criterion that matters? Because that is the main distinction between Schedule I and Schedule II, which includes tightly controlled medications such as opioid painkillers, methamphetamine, PCP, and cocaine. Under the CSA, Schedule II drugs have the same abuse potential as Schedule I drugs, but they have countervailing medical benefits.
The DEA maintains that the CSA does not allow it to move marijuana lower than Schedule II. The agency's position is based on the CSA's requirement that administrative scheduling decisions be consistent with "United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970." The Single Convention on Narcotic Drugs of 1961 requires restrictions on cannabis, including import licenses and production quotas, that do not currently apply to drugs in schedules lower than II. The DEA maintains that it would not have the authority to impose those restrictions on marijuana if the drug were moved to Schedule III or lower.
The CSA's deference to international agreements can lead to puzzling consequences, since the law says scheduling decisions should be made "without regard to" its usual criteria for classifying drugs when treaty obligations require a different result. That means the DEA can be required to put a drug into a category where it plainly does not belong. And according to the DEA's reading of the law, marijuana must be put in Schedule I or II even if it does not meet the criteria for those schedules. The DEA nevertheless argues that marijuana does meet the criteria for Schedule I.
Schedule I drugs are supposed to lack "accepted safety for use…under medical supervision." Contrary to Rosenberg's position, that criterion certainly sounds like it has something to do with marijuana's relative hazards. But the DEA seems to think that if a drug has no "accepted medical use," it cannot be safe to use under medical supervision.
That does not logically follow, especially for a drug that an administrative law judge who evaluated an earlier rescheduling petition called "one of the safest therapeutically active substances known to man." More than 1 million patients across the country are using marijuana at the recommendation of their doctors under state laws that allow medical use. They typically find that its side effects compare quite favorably to those of many FDA-approved pharmaceuticals—as Rosenberg concedes when he says marijuana is "less dangerous than some substances in other schedules."
Both Schedule I and Schedule II drugs are supposed to have "a high potential for abuse." As far as the DEA is concerned, the fact that many people like marijuana is enough to satisfy this criterion, since nonmedical consumption of a controlled substance automatically counts as abuse. The DEA notes that the FDA, which conducted a scientific review as part of the scheduling process prescribed by the CSA, "concluded that marijuana has a high potential for abuse based on a large number of people regularly using marijuana, its widespread use, and the vast amount of marijuana that is available through illicit channels." Those three factors collapse into one: Marijuana is popular, which you might think would count in its favor.
A narrower, harm-based definition of abuse would suggest that marijuana is not comparable to Schedule II drugs such as fentanyl, PCP, and methamphetamine. Nor is its potential for abuse "high" compared to those of Schedule III substances such as the anesthetic ketamine or the narcotic buprenorphine, or Schedule IV substances such as the benzodiazepine Rohypnol, the barbiturate phenobarbital, or the opioid painkiller Tramadol. Under the CSA, drugs in those categories are supposed to have lower abuse potential than drugs in Schedule I or II.
Schedule III, by the way, includes Marinol, which contains a synthetic version of THC, marijuana's main psychoactive ingredient. The FDA's report to the DEA, which the DEA published in the Federal Register along with its response to the rescheduling petitions, defends that inconsistency, arguing that orally ingested THC has less abuse potential than marijuana because recreational users prefer smoking pot. "The delayed onset and longer duration of action for Marinol may be contributing factors limiting the abuse or appeal of Marinol as a drug of abuse relative to marijuana," the FDA says. Never mind that THC-treated foods have proven very popular in states where marijuana is legal, or that critics of those products say the same factors the FDA thinks reduce abuse potential make edibles especially dangerous.
According to the CSA, abuse of Schedule II drugs "may lead to severe psychological or physical dependence." But that is not a requirement for the completely prohibited drugs in Schedule I, which in addition to marijuana include LSD and MDMA, neither of which invites heavy use because maximizing their enjoyable effects requires waiting between doses. In any case, the FDA says "marijuana produces physical dependence that is mild, short-lived, and comparable to tobacco withdrawal," which suggests it does not belong in Schedule II. The FDA also found "little evidence" to support the "gateway hypothesis" that marijuana consumption makes people more likely to abuse other drugs.
The FDA nevertheless argues that it does not make sense to contrast marijuana's hazards with those of Schedule II drugs such as morphine, amphetamines, and cocaine. It says "differing mechanism(s) of action result in vastly different behavioral and adverse effect profiles, making comparisons across the range of pharmacologically diverse C-II substances inappropriate." That's a puzzling argument, since the CSA requires comparisons across "pharmacologically diverse" substances as part of the scheduling process.
The difficulty in finding an appropriate schedule for marijuana reflects a broader problem with the CSA's classification scheme. If a controlled substance does not have an accepted medical use (however that's defined), it has to go in Schedule I, even if it has a low potential for abuse and is safer than over-the-counter drugs such as aspirin, acetaminophen, or diphenhydramine. The only alternative is to take the drug out of the schedules entirely, which in the case of marijuana can be done only by Congress, given the CSA's deference to the Single Convention, which allows medical use of cannabis but calls for strict regulation.
Although the DEA has the power to move marijuana from one schedule to another, it was Congress that put it in Schedule I to begin with. The CSA was not intended to regulate recreational intoxicants, which are banned unless Congress omitted them from the law's schedules, as it did with alcohol, tobacco, and caffeine. The DEA's assumption that all nonmedical use of marijuana constitutes abuse may be absurd, but it's an absurdity that Congress demanded.
This article originally appeared at Forbes.com.
