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Schedule I

  • by Paul Armentano, NORML Deputy Director September 5, 2012

    The oral administration of the non-psychotropic cannabis plant constituent cannabidiol (CBD) is safe and well tolerated in humans, according to clinical trial data published online by the journal Current Pharmaceutical Design.

    Investigators at Kings College in London assessed the physiological and behavioral effects of CBD and THC versus placebo in 16 healthy volunteers in a randomized, double-blind, crossover trial.

    Investigators reported that the oral administration of 10 mg of THC was associated with various physiological and behavioral effects – such as increased heart rate and sedation – whereas the oral administration of 600 mg of CBD was not.

    They concluded, “There were no differences between CBD and placebo on any symptomatic, physiological variable. … In healthy volunteers, THC has marked acute behavioral and physiological effects, whereas CBD has proven to be safe and well tolerated.”

    A previous review of the use of CBD in human subjects, published in the scientific journal Current Drug Safety last year, similarly concluded that the compound was safe, non-toxic, and well tolerated.

    Separate investigations of CBD have documented the cannabinoid to possess a variety of therapeutic properties, including anti-inflammatory, anti-diabetic, anti-epileptic, anti-cancer, and bone-stimulating properties. In recent years, patients in states that allow for the use of cannabis therapy, particularly California, have expressed an interest in plant strains that contain uniquely high percentages of the compound.

    Cannabidiol, because it is an organic component of cannabis, is presently classified under federal law as a schedule I prohibited substance. Such substances are required by law to possess “a high potential for abuse,” “a lack of accepted safety … under medical supervision,” and “no currently accepted medical use in treatment in the United States.”

    Full text of the study, “Acute effects of a single, oral dose of d9-tetrahydrocannabinol (THC) and cannabidiol (CBD) administration in healthy volunteers” appears online in Current Pharmaceutical Design.

  • by Paul Armentano, NORML Deputy Director August 9, 2012

    For the second time in recent months, a scientific paper published in a peer-reviewed journal has thoroughly rebutted the present Schedule I status of cannabis under US federal law, which states that the plant and its organic constituents possess a “high potential for abuse,” and that they lack “accepted medical use” and “accepted safety … under medical supervision.”

    According to a just published review in the German scientific journal Deutsches Ärzteblatt International, scientific findings from over 100 controlled clinical trials involving either cannabis or its constituents provide “clear evidence that cannabinoids are useful for the treatment of various medical conditions.”

    Investigators from the nova-Institute and the Hannover Medical School in Germany reviewed over 100 controlled trials assessing the safety and efficacy of cannabis and cannabinoids.

    Researchers reported: “Knowledge about the therapeutic potential of cannabis products has been greatly improved by a large number of clinical trials in recent years. … There is now clear evidence that cannabinoids are useful for the treatment of various medical conditions,” including chronic neuropathy (nerve pain), multiple sclerosis, HIV/AIDS, Gilles de la Tourette syndrome, and other indications.

    Regarding the safety profile of cannabis and cannabinoids, investigators determined: “The most common side effects of cannabinoids are tiredness and dizziness (in more than ten percent of patients), psychological effects, and dry mouth. Tolerance to these side effects nearly always develops within a short time. Withdrawal symptoms are hardly ever a problem in the therapeutic setting.”

    Authors did express concern that cannabis could pose additional health risks for adolescents and/or pregnant or breast-feeding women, as well as individuals diagnosed with Hepatitis C, severe cardiovascular disease, addictive disorders, or those vulnerable to certain psychiatric disorders, such as schizophrenia.

    Investigators acknowledged that cannabis dosing may adversely impact psychomotor skills. However, they noted, “Patients who take cannabinoids at a constant dosage over an extensive period of time often develop tolerance to the impairment of psychomotor performance, so that they can drive vehicles safely.”

    They concluded, “No acute deaths have been described that could be unequivocally attributed solely to cannabis consumption or treatment with cannabinoids.”

    This most recent paper follows the publication of a similar review, published in May in The Open Neurology Journal. In that paper, investigators with the University of California at San Diego and the University of California, Davis concluded: “Evidence is accumulating that cannabinoids may be useful medicine for certain indications. Based on evidence currently available, the (federal) Schedule I classification (of cannabis) is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.

    In 2011, the Obama administration — via the United States Drug Enforcement Administration (DEA) — formally denied a nine-year-old administrative petition filed by NORML and a coalition of public interest organizations calling on the agency to initiate hearings to reassess the present classification of marijuana as a schedule I controlled substance. In her denial of the petition, DEA administrator Michele Leonhart alleged: “[T]here are no adequate and well-controlled studies proving (marijuana’s) efficacy; the drug is not accepted by qualified experts. … At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”

    In June, Ms. Leonhart testified before Congress that she believed that heroin and marijuana posed similar threats to the public’s health because, in her opinion, “all illegal drugs are bad.”

    Coalition advocates are presently appealing the DEA’s denial of their petition in federal court.

    Full text of the most recent study, “The therapeutic potential of cannabinoids,” is available online here.

  • by Paul Armentano, NORML Deputy Director July 31, 2012

    As I wrote last week in an op/ed for The Sacramento Bee, when it comes to the federal government’s policy on marijuana, not so much.

    Viewpoints: Science supporting medicinal pot is clear
    via The Sacramento Bee

    A dozen years ago, California lawmakers did something extraordinary. They authorized investigators throughout California to conduct a series of FDA-approved, gold standard trials to assess whether cannabis is safe and effective as a medicine.

    In all, researchers conducted more than a dozen clinical studies examining whether cannabis could meet objective standards of safety and therapeutic efficacy. For example, investigators at the University of California, San Francisco, assessed whether vaporizing cannabis could rapidly and consistently deliver the plant’s active ingredients to patients in a manner that is far safer than smoking. It could. At UC San Diego, clinicians examined whether inhaling cannabis posed potential harms to the immune system, particularly in subjects suffering from immune-compromised conditions like HIV. It didn’t. And at universities throughout the state, investigators studied whether marijuana provided statistically significant relief in a number of hard-to-treat conditions, such as multiple sclerosis and neuropathic (nerve) pain. Cannabis did so – consistently.

    … Nonetheless, policymakers – particularly those in Washington – have responded to these most recent scientific findings with no more than a collective yawn. Despite pledging to let “science and the scientific process … inform and guide decisions of my administration,” neither President Barack Obama nor Congress have taken any steps to amend federal law or federal policy to reflect the scientific reality that marijuana possesses well-established therapeutic value. In fact, this administration has taken just the opposite approach.

    In 2011, the Obama administration quashed out-of-hand an administrative petition that sought federal hearings regarding the present classification of cannabis as a substance with “no currently accepted medical use in treatment in the United States.” In its rejection, the administration alleged, “The drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.”

    Yet, the findings from California’s 12-year-old study program show that each of these claims is demonstrably false.

    It is long past time to reject the notion that we as a society possess insufficient evidence regarding the safety and efficacy of cannabis. The truth is that we know plenty. Most of all we know that there remains no valid scientific reason to justify the continued targeting, prosecution and incarceration of those Americans who consume cannabis responsibly.

    Read my entire commentary here.

  • by Paul Armentano, NORML Deputy Director July 19, 2012

    A bipartisan coalition of Congressional lawmakers yesterday reintroduced federal legislation to provide state-authorized medical marijuana patients and their providers with an affirmative defense from federal prosecution.

    The legislation, H.R. 6134 –- The Truth in Trials Act (Read the text of the bill here.) –- would allow certain federal defendants the opportunity to “introduce evidence (at trial) demonstrating that the marijuana-related activities for which the person stands accused were performed in compliance with state law regarding the medical use of marijuana.”

    It states, “It is an affirmative defense to a prosecution or proceeding under any federal law for marijuana-related activities, which the proponent must establish by a preponderance of the evidence, that those activities comply with state law regarding the medical use of marijuana.”

    Fifteen Democrats and three Republicans are sponsoring the measure.

    Under present law, federal defendants are legally prevented from presenting evidence at trial that their actions were in compliance with state medical marijuana laws — or even acknowledging the fact that cannabis possesses therapeutic value — because the substance remains classified as a Schedule I prohibited substance under federal law. Passage of the Truth in Trials Act would ease these restrictions.

    House Bill 6134 is pending before the House Committee on the Judiciary, which is Chaired by ardent pot prohibitionist Lamar Smith (R-TX).

    Advocates can voice their support for The Truth in Trials Act to their members of Congress here.

    Of course, this legislation would not even be necessary were the Obama administration simply to have upheld the President’s one-time pledge to no longer use federal “Justice Department resources to try to circumvent state laws” regulating the physician authorized use and distribution of medical cannabis. You can tell President Obama to halt the administration’s escalating attack on medical cannabis here.

  • by Paul Armentano, NORML Deputy Director July 2, 2012

    The present classification of cannabis and its organic compounds as schedule I prohibited substances under federal law is scientifically indefensible, according to a just published review in The Open Neurology Journal.

    Investigators with the University of California at San Diego and the University of California, Davis reviewed the results of several recent clinical trials assessing the safety and efficacy of inhaled or vaporized cannabis. They concluded:

    “Evidence is accumulating that cannabinoids may be useful medicine for certain indications. Control of nausea and vomiting and the promotion of weight gain in chronic inanition are already licensed uses of oral THC (dronabinol capsules). Recent research indicates that cannabis may also be effective in the treatment of painful peripheral neuropathy and muscle spasticity from conditions such as multiple sclerosis. Other indications have been proposed, but adequate clinical trials have not been conducted.

    “… The classification of marijuana as a Schedule I drug as well as the continuing controversy as to whether or not cannabis is of medical value are obstacles to medical progress in this area. Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking. It is true cannabis has some abuse potential, but its profile more closely resembles drugs in Schedule III (where codeine and dronabinol are listed). The continuing conflict between scientific evidence and political ideology will hopefully be reconciled in a judicious manner.”

    The lead author of the review, Dr. Igor Grant, is the director of the Center for Medicinal Cannabis Research. In recent years, the CMCR has conducted various FDA-approved ‘gold standard’ clinical trials evaluating inhaled cannabis as a therapeutic agent. The results of several of those trials are summarized here.

    Under federal law, schedule I controlled substances are defined as possessing “a high potential for abuse, … no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision.” Heroin and Methaqualone (Quaaludes) are examples of other Schedule I substances.

    In 2011, the Obama administration — via the United States Drug Enforcement Administration (DEA) — formally denied a nine-year-old administrative petition filed by NORML and a coalition of public interest organizations calling on the agency to initiate hearings to reassess the present classification of marijuana as a schedule I controlled substance without any ‘accepted medical use in treatment.’ In her denial of the petition, DEA administrator Michele Leonhart alleged: “[T]here are no adequate and well-controlled studies proving (marijuana’s) efficacy; the drug is not accepted by qualified experts. … At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”

    Last month, Ms. Leonhart testified before Congress that she believed that heroin and marijuana posed similar threats to the public’s health because, in her opinion, “all illegal drugs are bad.”

    Coalition advocates are presently appealing the DEA’s denial of their petition in federal court.

    Full text of the paper from The Open Neurology Journal, entitled “Medical Marijuana: Clearing Away the Smoke,” is available online here.

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