When, in the waning days of the Obama administration, the government concluded that marijuana would continue to fall under Schedule I of the Controlled Substances Act, scientists weren’t surprised. After all, marijuana, according to the administration, “does not meet any of the five elements necessary for a drug to have a ‘currently accepted medical use.'”
That is why the recent recommendation to move marijuana to Schedule III by the Department of Health and Human Services (HHS) is so perplexing. To uphold public health and safety, as well as the sanctity of the drug approval process, the Drug Enforcement Administration (DEA) should unequivocally reject this politically motivated recommendation.
Scheduling reviews are meant to address a drug’s currently accepted medical use and its abuse potential. They have nothing to do with penalties or how we might expunge past convictions for low level possession.
But HHS decided to make this political, and that’s wrong. The FDA has long used a five-factor test to determine currently accepted medical use for Schedule I drugs. It states that (1) the drug’s chemistry must be known and reproducible, (2) there must be adequate safety studies, (3) there must be adequate and well-controlled studies proving efficacy, (4) the drug must be accepted by qualified experts, and (5) the scientific evidence must be widely available. All five of these standards must be met to find that a drug has currently accepted medical use.
Knowing marijuana would again fail to meet these accepted standards, the FDA decided to predetermine the outcome. Using a new, unprecedented two-factor test, which simply looked at whether so-called “medical marijuana” is recommended by licensed health care practitioners and whether there is evidence of marijuana’s efficacy for at least one medical condition, political leaders at the department finally got the results they were seeking.
Incredibly, they cheered the announcement at 4:20 p.m., a nod to a common stoner joke. And we’re supposed to take this review seriously?
HHS and FDA are trying to make us believe that if a drug is “accepted” by some, then it can be reclassified. This sets a dangerous precedent. Since it unilaterally lowered the bar for marijuana, the FDA could do the same for any other drug that is deemed politically expedient.
The next step is to determine the drug’s abuse potential. To do this, the FDA compared marijuana to a short, seemingly random list of “comparator drugs.” Again, the FDA defied precedent and distorted the process to get the answer it wanted. Of the nine scheduled substances included, five were opioids, which have fueled the overdose epidemic. Though alcohol is not a scheduled substance and is not included in scheduling reviews, it was included in this review to make marijuana appear less harmful.
Ketamine, a Schedule III drug, was the only hallucinogen that was included. If other hallucinogens had been included as comparators – such as LSD or psilocybin, both Schedule I substances –marijuana would have had a much greater perceived potential for abuse, rendering its current Schedule I designation appropriate. Compared to users of hallucinogens, users of marijuana are much more likely to develop a substance use disorder and be admitted to treatment for their use, hence marijuana’s greater abuse potential than other Schedule I drugs.
Surprisingly, no stimulants were included in the review, though Schedule II drugs like Adderall and Ritalin would have been fitting. The FDA also did not include any substances in Schedule V.
The FDA’s review was also expected to look at the drug’s risks to public health. However, they failed to look at the impact of marijuana on pregnant women or the likely rise in traffic fatalities due to marijuana-impaired driving, despite both considerations being included in the 2016 rescheduling review. The process was clearly tainted to get the most politically expedient answer. It’s hard to miss the broader timing of the process given the upcoming election.
Ultimately, though, final authority rests with the DEA, not the FDA.
Even if one finds that marijuana has currently accepted medical use, marijuana still should not be placed in Schedule III. The Controlled Substances Act stipulates: “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 to carry out such obligations, without regard to the findings” from the FDA.
The United States is also a signatory to the United Nations’ 1961 Single Convention on Narcotic Drugs, which requires that marijuana and other drugs be scheduled. When the DEA last rejected the rescheduling of marijuana, it said that “I and II are the only possible schedules in which marijuana may be placed” to maintain compliance with the treaty.
In alignment with their previous position that marijuana must be placed in either Schedule I or II, the DEA should reject the Schedule III recommendation “without regard” to the FDA’s flawed review. Anything less would put the United States out of compliance with the UN treaty. If the United States breaks its obligations under this treaty, it will damage our credibility regarding other treaties.
It’s abundantly clear that the FDA rescheduling review was guided by politics, not science and medicine. Though marijuana is still not approved by the FDA for the treatment of any disease or condition, the agency wrongly asserted that marijuana has currently accepted medical use. To protect the integrity of rescheduling and the drug approval process, and to uphold America’s obligations to international treaties, the DEA must reject HHS’s recommendation.
Kevin A. Sabet, Ph.D., is the President of Smart Approaches to Marijuana (SAM) and a former White House drug policy advisor to Presidents Obama, Bush, and Clinton.
The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller.