Over 2,500 Subjects Since 2005 Have Used Marijuana-Based Medicines In Controlled Clinical Trials

[Editor's note: This post is excerpted from this week's forthcoming NORML weekly media advisory. To have NORML's media advisories delivered straight to your in-box, sign up for NORML's free e-zine here.]

Researchers worldwide have performed 37 separate clinical trials assessing the therapeutic safety and efficacy of inhaled cannabis and marijuana-based medicines since 2005, according to a review published online last week in the journal Cannabinoids: The Journal of the International Association for Cannabinoid Medicines (IACM).

Investigators from Leiden University in the Netherlands and the nova-Institut in Germany conducted a systematic review of recent clinical trial data pertaining to the medical use of whole smoked marijuana and cannabinoids.

Authors identified 37 controlled studies since 2005 evaluating the therapeutic effects of cannabinoids. The trials involved a total of 2,563 subjects.

Of the 37 clinical trials that have been recently conducted, eleven assessed the drug’s impact on chronic neuropathic pain – a difficult to treat type of pain resulting from nerve damage. Other studies assessed the efficacy of cannabinoids to treat multiple sclerosis-associated spasticity (nine separate studies); HIV/AIDS (four); experimental pain (four); intestinal dysfunction (two); nausea/vomiting/appetite (two); schizophrenia (two); glaucoma (one); and ‘other indications (two).

Authors concluded, “Based on the clinical results, cannabinoids present an interesting therapeutic potential mainly as analgesics in chronic neuropathic pain, appetite stimulants in debilitating diseases (cancer and AIDS), as well as in the treatment of multiple sclerosis.”

Last Wednesday investigators from the California Center for Medicinal Cannabis Research released the results of a series of double-blind, placebo-controlled trials that determined that cannabinoids could be “a first-line treatment” for patients suffering from neuropathy.

Commenting on the review, NORML Deputy Director Paul Armentano said: “The safety and efficacy of marijuana as a medicine has now been established by the ‘gold standard’ of clinical study. Further, over 2,500 patients have used cannabinoids in controlled clinical trials over the past five years alone. This is a far greater total than the number of subjects that would likely be administered any other new drug pending United States FDA approval, and is a large enough population to once and for all establish marijuana’s objective value as a medicine.”

‘Gold Standard’ Studies Show That Inhaled Marijuana Is Medically Safe And Effective

The results of a series of randomized, placebo-controlled clinical trials assessing the efficacy of inhaled marijuana consistently show that cannabis holds therapeutic value comparable to conventional medications, according to the findings of a 24-page report issued earlier today to the California state legislature by the California Center for Medicinal Cannabis Research (CMCR).

Four of the five placebo-controlled trials demonstrated that marijuana significantly alleviated neuropathy, a difficult to treat type of pain resulting from nerve damage.

“There is good evidence now that cannabinoids (the active compounds in the marijuana plant) may be either an adjunct or a first-line treatment for … neuropathy,” said Dr. Igor Grant, Director of the CMCR, at a news conference at the state Capitol.  He added that the efficacy of smoked marijuana was “very consistent,” and that its pain-relieving effects were “comparable to the better existing treatments” presently available by prescription.

A fifth study showed that smoked cannabis reduced the spasticity associated with multiple sclerosis.  A separate study conducted by the CMCR established that the vaporization of cannabis – a process that heats the substance to a temperature where active cannabinoid vapors form, but below the point of combustion – is a “safe and effective” delivery mode for patients who desire the rapid onset of action associated with inhalation while avoiding the respiratory risks of smoking.

Two additional clinical trials remain ongoing.

The CMCR program was founded in 2000 following an $8.7 million appropriation from the California state legislature.  The studies are some of the first placebo-controlled clinical trials to assess the safety and efficacy of inhaled cannabis as a medicine to take place in over two decades.

Placebo-controlled clinical crossover trials are considered to be the ‘gold standard’ method for assessing the efficacy of drugs under the US FDA-approval process.

“These scientists created an unparalleled program of systematic research, focused on science-based answers rather than political or social beliefs,” said former California Senator John Vasconcellos, who sponsored the legislation in 1999 to launch the CMCR.  Vasconcellos called the studies’ design “state of art,” and suggested that the CMCR’s findings “ought to settle the issue” of whether or not medical marijuana is a safe and effective medical treatment for patients.

“This (report) confirms all of the anecdotal evidence – how lives have been saved and pain has been eased,” said California Democrat Senator Mark Leno at the press conference.  “Now we have the science to prove it.”

Full text of the CMCR’s report to the California legislature is available at online at: http://www.cmcr.ucsd.edu/CMCR_REPORT_FEB17.pdf.

AMA Calls For Ending The “Schedule I Lie”

The Schedule I federal classification of cannabis — which states that, by law, the marijuana plant and its natural compounds have “no currently accepted medical use in treatment in the United States” — has long since passed the point of farcical. Nevertheless, defenders of the so-called “Schedule I lie” have possessed, for nearly 30 years, one prestigious ally that they could always rely on to endorse their absurd position: the American Medical Association.

Not anymore!

Today the AMA voted to reverse its longstanding endorsement of cannabis’ Schedule I prohibitive status. The vote took place during the organization’s annual Interim Meeting of the House of Delegates in Houston, Texas, and marks the first time that the AMA has revisited its position on cannabis in eight years.

As newly amended, the AMA’s official position (see specifically pages 12, 13, and 14) regarding the medical use of cannabis no longer “recommends that marijuana be retained in Schedule I of the Controlled Substances Act.” Rather, the Association now resolves “that marijuana’s status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines.”

The AMA also today demolished long-held pot prohibitionist claim — frequently publicized by the White House Office of National Drug Control Policy and others — that “no sound scientific studies have supported medical use of smoked marijuana for treatment in the United States, and no animal or human data support the safety or efficacy of smoked marijuana for general medical use.” To the contrary, the AMA has adopted a report drafted by its Council on Science and Public Health (CSAPH) entitled, “Use of Cannabis for Medicinal Purposes,” which states, “Results of short term controlled trials indicate that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with multiple sclerosis.”

Now that the AMA has finally acknowledged reality, is anyone else wondering if David Evans (or the DEA) will finally update their talking points?