Medical Marijuana Research Moves Forward

Departments - Upfront | Medically Speaking

Following her opponent Bernie Sanders’s introduction of a Senate bill to end federal marijuana prohibition, presidential hopeful Hillary Clinton called recently for the plant to be reclassified by the government from a Schedule 1 to a Schedule 2 substance.

Both candidates’ announcements followed President Obama’s ruling last June to remove the highly limiting Public Health Service Review that required an individual review of every marijuana-research application.

The plant’s Schedule I classification makes it difficult for even established facilities to conduct research on the medical efficacy of marijuana and its cannabinoids, such as cannabidiol (CBD).

But even states that have not yet legalized or decriminalized marijuana are beginning to break down barriers to research. Delaware (which decriminalized possession of small amounts of marijuana effective in December 2015) and Pennsylvania are among those leading the way.

Delaware: Research Approved, But Yet to Begin

Delaware lawmakers in January 2015 established the legal framework to allow facilities to research marijuana’s potential medicinal benefits.

Wayne Smith, president and CEO of the Delaware Healthcare Association, says he isn’t aware of any facilities in the state doing research yet under the new legislation.

Dale Ervin, director of operations for the Fraunhofer Center (which also supported the legislation), says, “As of right now, we aren’t doing any research. But, the Center is “in the process of getting facilities and protocols in place,” she says.

Photo: © Thomas Morris | Dreamstime.com

Pennsylvania: Research Program in Early Stages

In November 2015, the Pennsylvania Department of Health (DOH) opened the application process for qualified research facilities to compete for $2 million in funding from the Commonwealth Universal Research Enhancement Program (CURE) to support the study of CBD in treating children with epilepsy and other neurological diseases who suffer from medication-resistant seizures.

The application deadline was Dec. 8, 2015, and grantees will be selected by June.

“We are still in the very beginning stages of this process and have not selected a research entity for this study,” Pennsylvania Secretary of Health Karen Murphy says.

To secure cannabidiol for the research project, the Pennsylvania DOH entered into an agreement with a pharmaceutical-grade CBD manufacturer, which will provide a free, yearlong course of treatment for 50 pediatric patients.

Awardees will need appropriate Schedule I licensing.

A Research Conundrum

Marijuana is stuck in its Schedule 1 classification because it has been deemed to have no true medicinal benefits. But that classification is the very thing that hinders research to uncover its medicinal benefits.

A report issued in October 2015 by the Brookings Institution, a nonprofit organization devoted to independent research and policy solutions, decried the plant’s Schedule I classification and the tangled web of bureaucracy, restrictions and hoop-jumping that plague researchers even in states where medical marijuana use is legal.

The Brookings report also called for an end to the DEA-mandated monopoly on marijuana grown for research. Currently, all marijuana for federally approved studies comes from a lab at the University of Mississippi, which has been the sole U.S. provider of marijuana for scientific and medical researchers since 1968.

“Because of this monopoly, research-grade drugs that meet researchers’ specifications often take years to acquire, if they are produced at all,” the report stated.

The University of Mississippi’s contract with NIH’s National Institute on Drug Abuse was renewed in March 2015.

About the Author: Margaret Battistelli Gardner is a freelance writer and the editor of Marketing AdVents magazine, the member publication of the Direct Marketing Association of Washington, D.C. She can be reached at megmgardner@aol.com.