UCSF Study Shows Medical Marijuana Effective in HIV-Associated Neuropathy
First FDA-approved clinical trial since passage of Prop. 215

Cal NORML Release Feb 12, 2007

For years, the DEA has been demanding controlled, FDA-approved studies showing efficacy of medical marijuana. Today, the publication of the first such study in two decades, by Dr. Donald Abrams at UCSF, has been announced by the journal Neurology. The study shows that marijuana is effective in reducing pain from HIV-related neuropathy, as patients have long reported.

The study is the first of a dozen clinical studies sponsored by California's Center for Medical Cannabis Research to reach publication. Others are in the final stages of completion. The CMCR was founded in 2000, and it has taken 7 years to reach this point. Much credit goes to the foresight of Sen. John Vasconcellos for sponsoring the legislation establishing the CMCR.

The question remains, how much longer will the federal government keep marijuana illegal in the face of the scientific evidence? Opponents can rightly contend that this single study was not part of a formal FDA new drug application, and therefore can't be used for new drug approval. A proposal by Prof. Lyle Craker of U. Mass to establish a research garden to begin new drug development has been blocked by DEA.

In another breaking development, DEA Administrative Law Judge Mary Ellen Bittner today ruled that Prof. Crakers' application should be approved. Even if the DEA accepts the ruling, however, we can expect it will take at least seven more years to approach new drug approval.

In the meantime, how many more Americans will be wrongfully arrested on account of the government's refusal to allow legal medical use of marijuana?

Inhaled Cannabis Significantly Reduces HIV-Associated Neuropathy

by Paul Armentano, NORML Senior Policy Analyst

Cannabis significantly reduces HIV-associated neuropathic pain compared to placebo, and possesses an acceptable margin of safety for use, according to clinical trial data published today in the journal Neurology.

Investigators at San Francisco General Hospital and the University of Californiaıs Pain Clinical Research Center assessed the efficacy of inhaled cannabis on HIV-associated sensory neuropathy in 50 volunteers participating in a five-day double-blind, placebo-controlled trial. Researchers reported that smoking low-grade cannabis (3.56 percent THC) three times daily reduced patientsı pain by 34 percent.

"Thirteen of 25 patients randomized to cannabis cigarettes had >30 percent in pain from baseline to end of treatment versus 6 of 25 patients receiving placebo cigarettes," authors wrote. A 30 percent reduction in pain is considered to be a clinically meaningful amount of pain relief.

Investigators added: "Smoking the first cannabis cigarette reduced chronic pain ratings by a median of 72 percent versus a reduction of 15 percent with placebo [zero THC] cigarettes. On day five, just prior to smoking the last cigarette, median ratings of current chronic pain intensity were lower in the cannabis group than in the placebo group. Smoking the last cigarette further reduced chronic pain ratings 51 percent in the cannabis group versus five percent in the placebo group."

They concluded: "Smoked cannabis was well tolerated and effectively relieved chronic neuropathic pain from HIV-associated neuropathy [in a manner] similar to oral drugs used for chronic neuropathic pain."

The lead investigator of the study, Donald Abrams of San Francisco General Hospital, initially sought federal approval to assess the potential medical efficacy of cannabis in HIV patients in 1994, but was repeatedly denied access to the US governmentıs supply of research-grade marijuana.

Previous clinical trials assessing the use of cannabinoids as analgesics have demonstrated that they can significantly reduce the neuropathy associated with multiple sclerosis, diabetes, cancer, and rheumatoid arthritis.

Neuropathic pain affects an estimated one percent of the world's population and is typically unresponsive to both opioids and non-steroidal anti-inflammatory drugs such as ibuprofen.

Full text of the study, "Cannabis in painful HIV-associated sensory neuropathy," appears in the Feb. 13th issue of Neurology.

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