The Marijuana Re-Schedule

It was good news and bad news this week for those who wish to legalize marijuana when the Drug Enforcement Administration (DEA) declined to re-schedule marijuana from a Schedule I to Schedule II drug. (Statement 1, Statement 2) The ruling came in response to two petitions – one from the governors of Rhode Island and Washington and one from a resident of New Mexico – asking for the reschedule. On the other hand, the agency also announced new procedures that should increase research opportunities. (For the full DEA decision in the Federal Register, click here.)

Marijuana Research

The University of Mississippi has had a stranglehold on the growing of research marijuana since 1968. The change in the DEA’s policy will allow commercial growers to sell marijuana for research purchases and potentially for commercial use as well according to Dr. Sue Sisley, a researcher interested in studying the medical efficacy of marijuana on PTSD. She has DEA approval for such a study with military veterans.  This change in policy should make it easier for researchers to purchase plants with various levels of THC compared to the very low levels grown by Ole Miss.

The Controlled Substances Act requires scheduling decisions be based on scientific data, not politics or public opinion. “The scientific evidence of [marijuana’s] effectiveness is thin to nonexistent for many illnesses, including rheumatoid arthritis, Tourette’s syndrome and lupus,” according to the New York Times.  However, reputable studies have shown it can “relieve nausea, improve appetite and ease painful spasms.” One opponent of the reschedule called the DEA decision “a victory for science.”

Although most people, including Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws (NORML), believe the potential for more research is going to be available, some remain skeptical that the DEA policies will ever lead to an increase in research. “It’s just the same runaround that we’ve been hearing for years,” said Steve DeAngelo, the founder and CEO of Harborside Health Center in Oakland, CA. An editorial in The New York Times asserted that keeping marijuana on Schedule I “means that scientists have to obtain multiple approvals from different federal agencies…to conduct research.” Moreover, it said, the government makes it easier to study opioids and other dangerous drugs.

A Review of Current Research

The Food and Drug Administration (FDA) reviewed 23 clinical studies “investigating the use of marijuana in any therapeutic areas.” Eleven studies met the FDA criteria of relevancy “if the investigators administered marijuana to patients with a diagnosed medical condition in a well-controlled, double-blind, placebo-controlled clinical trial.” “[T]he studies reviewed produced positive results, suggesting marijuana should be further evaluated as an adjunct treatment for neuropathic pain, appetite stimulation in HIV patients, and spasticity in MS patients.”

Limitations on Current Relevant Research

The FDA found some significant limitations on the studies:

• • The small numbers of subjects enrolled in the studies, which limits the statistical analyses of safety and efficacy.
  • The evaluation of marijuana only after acute administration in the studies, which limits the ability to determine efficacy following chronic administration.
  • The administration of marijuana typically through smoking, which exposes ill patients to combusted material and introduces problems with determining the doses delivered.
  • The potential for subjects to identify whether they received marijuana or placebo, which breaks the blind of the studies.
  • The small number of cannabinoid naïve subjects, which limits the ability to determine safety and tolerability in these subjects.
  • The low number of female subjects, which makes it difficult to generalize the study findings to subjects of both genders.

Electoral Politics and the Marijuana Re-Schedule

So what does the refusal for the marijuana re-schedule mean to the states? It maintains the status quo with 25 states, the District of Columbia and Puerto Rico legalizing marijuana for medical purposes and four states plus D.C. legalizing recreational use. Recreational marijuana is on the ballot in Arizona, California, Maine, Massachusetts and Nevada; Arkansas and Florida will be voting on medical use. Many believe that public opinion has gotten ahead of science on this issue.

Hillary Clinton’s campaign reiterated that she would change the scheduling from I to II if she becomes president. It is not clear how she would do this without Congressional approval however. According to Time magazine, her spokesperson said, “As Hillary Clinton has said throughout this campaign, we should make it easier to study marijuana so that we can better understand its potential benefits, as well as its side effects.” Donald Trump has remained opposed to re-schedule marijuana or the legalization of recreational marijuana but says the states should set their own policies.

What do you think?