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Schedule I

  • by Erik Altieri, NORML Executive Director January 22, 2013

    In a 28-page decision, the US Court of Appeals for the District of Columbia Circuit has denied petitioners request to overturn the July 2011 denial by the Drug Enforcement Administration to initiate proceedings to reschedule marijuana under federal law.

    In October 2002, the Coalition to Reschedule Cannabis, a coalition of reform organizations including NORML, ASA, Patients Out of Time and High Times, among others, petitioned the DEA to reschedule marijuana as a Schedule III, IV, or V drug. Following years of administrative delay, on July 8, 2011, the DEA denied the petition, finding that “[t]here is no currently accepted medical use for marijuana in the United States,” and that “[t]he limited existing clinical evidence is not adequate to warrant rescheduling of marijuana under the CSA.”

    Petitioners then sought review in the federal Court of Appeals, alleging the decision by the DEA was arbitrary and capricious when it concluded that marijuana lacks a “currently accepted medical use” and has a “high potential for abuse.” They ask this court to remand the case to the DEA for reconsideration of its decision.

    Written by Senior Circuit Judge Edwards, the decision ruled “On the record before us, we hold that the DEA’s denial of the rescheduling petition survives review under the deferential arbitrary and capricious standard. The petition asks the DEA to reclassify marijuana as a Schedule III, IV, or V drug, which, under the terms of the CSA, requires a ‘currently accepted medical use.’ The DEA’s regulations, which we approved in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), define ‘currently accepted medical use’ to require, inter alia, ‘adequate and well-controlled studies proving efficacy.’ Id. at1135. We defer to the agency’s interpretation of these regulations and find that substantial evidence supports its determination that such studies do not exist.

    “In its scientific and medical evaluation,” the court held, “DHHS concluded that marijuana lacks a currently accepted medical use in the United States. In reaching this conclusion, DHHS applied the DEA’s established five-prong test, which requires a known and reproducible drug chemistry, adequate safety studies, adequate and well-controlled studies demonstrating efficacy, acceptance of the drug by qualified experts, and widely available scientific evidence.”

    “We will not disturb the decision of an agency that has ‘examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made.’”

    In this case, we need only look at one factor, the existence of “adequate and well-controlled studies proving efficacy,” to resolve Petitioners’ claim.

    At bottom, the parties’ dispute in this case turns on the agency’s interpretation of its own regulations. Petitioners construe “adequate and well-controlled studies” to mean peer-reviewed, published studies suggesting marijuana’s medical efficacy. The DEA, in contrast, interprets that factor to require something more scientifically rigorous.

    In making this assessment, we must “remind ourselves that our role in the Congressional scheme is not to give an independent judgment of our own, but rather to determine whether the expert agency entrusted with regulatory responsibility has taken an irrational or arbitrary view of the evidence assembled before it.

    The DEA’s construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agency’s interpretation of “adequate and well-controlled studies.” Judged against the DEA’s standard, we find nothing in the record that could move us to conclude that the agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist.”

    Petitioners are considering their legal options at this time.

  • by Paul Armentano, NORML Deputy Director October 10, 2012

    The U.S. Court of Appeals for the D.C. Circuit will hear opening arguments next week in a lawsuit challenging the federal government’s refusal to consider reclassifying cannabis as a schedule I prohibited substance under federal law.

    At issue in the case is whether the Drug Enforcement Administration (DEA) acted appropriately when the agency last year denied an administrative petition – initially filed by a coalition of public interest organizations, including NORML, in 2002 – that called on the agency to initiate hearings to reassess the present classification of cannabis.

    Under federal law, schedule I substances must possess three specific criteria: “a high potential for abuse;” “no currently accepted medical use in treatment;” and “a lack of accepted safety for the use of the drug … under medical supervision.” In its 2011 denial of petitioners’ rescheduling request, DEA Administrator Michele Leonhart alleged that cannabis possesses all three criteria, claiming: “[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.”

    By contrast, a recent scientific review of clinical trials evaluating the safety and efficacy of cannabis concluded, “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.”

    Commenting on the upcoming hearing in a press release, Joe Elford, Chief Counsel with Americans for Safe Access (ASA) said: “Medical marijuana patients are finally getting their day in court. What’s at stake in this case is nothing less than our country’s scientific integrity and the imminent needs of millions of patients.” Elford will be arguing the case before the D.C. Circuit. Oral arguments in the case are scheduled for Tuesday, October 16th.

    NORML previously filed a similar rescheduling petition with the DEA in 1972, but was not granted a federal hearing on the issue until 1986. In 1988, DEA Administrative Law Judge Francis Young ruled that marijuana did not meet the legal criteria of a Schedule I prohibited drug and should be reclassified. Then-DEA Administrator John Lawn rejected Young’s determination, a decision the D.C. Court of Appeals eventually affirmed in 1994.

    A subsequent petition was filed by former NORML Director Jon Gettman in 1995, but was rejected by the DEA in 2001.

    Further information on the lawsuit is available at: http://safeaccessnow.org. Additional information on the 2002 petition to reschedule cannabis is available at: http://www.drugscience.org/.

  • 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.

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