Pot Initiatives Up in Smoke

Despite a growing number of states looking at legalizing marijuana for both medicinal and recreational purposes, the drug will remain a “Schedule I” offense under the Controlled Substances Act (CSA), the Drug Enforcement Agency announced on its website Thursday.

The federal government renewed its stance this week that there is little scientific evidence to date to prove the drug’s therapeutic value. “Schedule I” means it will continue to be classified as a drug with “no currently accepted medical use and a high potential for abuse,” which prevents doctors from legally prescribing it.

“There are people making a lot of money off selling the whole plant and making medical claims,” said one drug policy expert.

“The DEA and the FDA [Food and Drug Administration] continue to believe that scientifically valid and well-controlled clinical trials conducted under investigational new drug (IND) applications are the most appropriate way to conduct research on the medicinal uses of marijuana,” a statement read Thursday on dea.gov.

“Furthermore, DEA and FDA believe that the drug approval process is the most appropriate way to assess whether a product derived from marijuana or its constituents is safe and effective and has an accepted medical use. This pathway allows the FDA the important ability to determine whether a product meets the FDA criteria for safety and effectiveness for approval.”

The decision was in response to two pending petitions to reschedule the classification of marijuana.

The ruling reaffirms what folks who have been following this issue closely already know, said Jeffrey Zinsmeister, a senior fellow at the University of Florida Drug Policy Institute and an executive vice president at Smart Approaches to Marijuana (SAM).

“Obviously there are compounds in the marijuana plant that show promise as pharmaceuticals, but the whole plant — there is not enough science to support the determination of the whole plant with all of its 200 to 300 compounds as a dose for safe medication,” Zinsmeister told LifeZette.

The DEA is expanding research on medicinal use of the plant and “that’s what this [ruling] does.”

“These initiatives really are ultimately about money more than science — there are people making a lot of money off selling the whole plant and making medical claims,” he added.

What is clear with the new ruling, and perhaps the most important aspect of the latest decision on the drug, said Zinsmeister, is that the DEA is expanding research on medicinal use of the plant and “that’s what this does.”

“The Obama administration’s executive branch is saying, ‘The science isn’t there yet; we’re going to put more emphasis on legitimate research.’ Frankly, the bottom line on this is: the federal government is committed to the FDA approval process for medications — they have to go through a process that’s based on science, and the research on this just isn’t there yet.”

The DEA announced it will expand the number of DEA-registered marijuana manufacturers, offering researchers “a more varied and robust supply of marijuana.” Currently, there is only one entity authorized to produce marijuana to supply researchers in the United States: the University of Mississippi, operating under a contract with the National Institute for Drug Abuse.

Consistent with the CSA and U.S. treaty obligations, DEA’s new policy will allow additional entities to apply to become registered with the DEA so that they may grow and distribute marijuana for FDA-authorized research purposes.

[lz_ndn video=31257948]

Twenty-five states and the District of Columbia have passed laws allowing medical use of marijuana. Zinsmeister said he doesn’t see anything changing where laws already in place — adding that the DEA isn’t interested in arresting people for low-level possession.

But what should change is that the research will start to support what — if any — elements can be classified as safe for “medication” in a plant that otherwise contains 200 to 300 compounds.

“The whole plant is not medication in the sense that we use it for FDA-approved medications. There are compounds of it that are — but right now they can’t be dosed. What you buy in Topeka is different from what you buy in Los Angeles, what you buy in Seattle, and what you buy in Denver. You’re talking about something that hasn’t been standardized through the series of clinical trials that the Department of Health uses for all drugs — the science is just not there yet.”