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In Parting Shot, Bush's DEA Blocks FDA Research Route for Medical Marijuana

Jag Davies,
Drug Law Reform Project
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January 16, 2009

(Originally posted on Daily Kos.)

In a devious 11th-hour move to undermine scientific freedom, the Bush administration dealt a serious blow this week to the effort to bring medical marijuana before the Food and Drug Administration (FDA).

Way back in 2001, University of Massachusetts-Amherst Professor Lyle Craker applied to the Drug Enforcement Administration (DEA) for a Schedule I license to cultivate research-grade marijuana for use by scientists in FDA-approved studies aimed at developing the drug as a legal, prescription medication. After years of DEA stonewalling, in February 2007 the DEA’s Administrative Law Judge issued a decisive — but nonbinding — recommendation that Professor Craker’s application be approved. Now, after taking its sweet time for 23 months, the DEA finally got around to issuing a formal rejection of the Judge’s recommendation, less than two weeks before Bush leaves office.

Like abstinence-only education and research into global warming, DEA’s decision to obstruct FDA-approved research is an inappropriate insertion of political ideology into science. Why is the federal government going to such lengths to stop Lyle Craker? Clearly, it realizes that if the FDA has the opportunity to evaluate medical marijuana based on science, not politics,it would likely approve it for medical use.

Although the DEA has licensed multiple privately-funded manufacturers of all other Schedule I drugs, for four decades the DEA has permitted only one person to produce marijuana for research purposes, under contract with the National Institute on Drug Abuse (NIDA). With its monopoly power, NIDA has systematically blocked FDA-approved research seeking to determine whether marijuana meets the FDA’s standards for medical safety and efficacy. Even for researchers whose protocols it approves, NIDA provides inferior, low-potency marijuana with limited cannabinoid profiles. To put the nail in the coffin, NIDA cannot guarantee that the same material will be available for prescription use should FDA determine that safety and efficacy has been proven. This makes any drug development effort using NIDA marijuana a futile exercise.

As a result, pharmaceutical companies interested in making marijuana a prescription medicine are impeded by NIDA’s monopoly — not a single private company is investing in marijuana research.

The DEA and NIDA have successfully created a catch-22 for patients, doctors and scientists by denying that marijuana is a medicine because it is not approved by the FDA, while simultaneously obstructing the very research that would be required for FDA to approve marijuana as a medicine.

As a result of the federal government’s longtime obstruction of marijuana drug development research, 13 states have used political mechanisms to protect patients who use marijuana for legitimate medical purposes. Ultimately, the DEA is not only destroying its remaining shreds of credibility, but also shooting itself in the foot — thanks to this recent decision, more states will be compelled to approve medical marijuana since, nationally, three-quarters of voters support it.

Sick people who depend on medical marijuana are hoping that Obama’s DEA will bring an end to this disgraceful farce. In addition, 45 members of the U.S. House of Representatives, Massachusetts Senators John Kerry and Edward Kennedy, and a broad range of scientific, medical and public health organizations have written in support of Professor Craker, including the Lymphoma Foundation of America, the National Association for Public Health Policy, the Multiple Sclerosis Foundation, as well as several state medical and nurses’ associations.

Fortunately, the incoming administration has signaled that it will take a different approach than the outgoing one. Last spring, the Obama campaign told the LA Times:

“Obama supports the rights of states and local governments to make this choice — though he believes medical marijuana should be subject to [U.S. Food and Drug Administration] regulation like other drugs.”

Well, here’s his chance. Medical marijuana can only “be subject to regulation like other drugs” if legitimate, privately-funded FDA-approved research is allowed to proceed as it can for any other drug. Will Obama have the courage and common sense to let science resolve the controversy over medical marijuana? We’ll find out soon.

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