Proponents: Government stifling medical marijuana researchNeither state legislatures nor ballot initiatives are the proper place to approve marijuana for medical use, critics of legalization say.
By: John Lundy, Duluth News Tribune
Neither state legislatures nor ballot initiatives are the proper place to approve marijuana for medical use, critics of legalization say.
The Minnesota Law Enforcement Coalition quotes an advisory issued by the Food and Drug Administration in 2006. “These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective,” the advisory said.
The FDA has approved two drugs, Marinol and Cesamet, that “contain active ingredients that are present in botanical marijuana,” spokeswoman Morgan Liscinsky said.
FDA supports marijuana research in line with its drug-approval process, Liscinsky said. But the fact that it’s a Schedule I substance — meaning it’s regarded as having a high potential for abuse and no accepted medical use — means the research is subject to stringent restrictions.
Among other things, she said, the research protocol has to be registered with the Drug Enforcement Agency, and each study requires a Schedule I license from the DEA.
There’s the rub, say legalization supporters, who accuse the DEA of squelching research.
“Research has been completely stifled by the federal government,” said Heather Azzi, political director of the pro-legalization group Minnesotans for Compassionate Care. States started to take the lead because of that, she said.
One of the issues is the Schedule I label, used to indicate a drug has “no currently accepted medical use” and a “high potential for abuse” in FDA’s hierarchy.
“Now the FDA a number of times has requested from the DEA to allow them to do research on medical marijuana,” said state Rep. Carly Melin, DFL-Hibbing. “They’ve asked them to reschedule it and no longer have it as a Schedule I drug and to allow them to conduct medical research, and the DEA has not permitted the FDA to do that.”
But Liscinsky said marijuana has been the subject of several rescheduling petitions since 1972 and that the FDA made its own call on the subject.
“FDA evaluated marijuana based on the scientific data available,” she said, and recommended to the U.S. Department of Health and Human Services that it remain a Schedule I substance.
Azzi said the DEA controls the legal supply of marijuana, which is grown in Mississippi. The DEA refuses to release marijuana for medical research that otherwise meets FDA criteria, she said.
DEA spokesman Joseph Moses denied that claim.
The agency doesn’t control the supply of marijuana, he said, although it does have a role in approving the research. The DEA denies proposals that fail to meet required safeguards, he said, but it has registered about 300 researchers to study marijuana or its derivatives.
He was uncertain what percentage of proposals the DEA rejects.
A search under “marijuana” in the U.S. National Institutes of Health website ClinicalTrials.gov reveals 374 studies in various stages. The majority appear to involve treatment for marijuana dependence or withdrawal, or a look at the drug’s ill effects.
But some look at the possible medical uses of marijuana. One, in the recruiting stage, will look at the effect of vaporized cannabis on spinal cord injury pain. Another, marked as “completed” but not “has results,” sought “to determine if smoking marijuana will reduce neuropathic pain without causing too much drowsiness or feeling ‘too dopey.’ ”