Members of Congress reintroduced legislation this week to protect state-authorized medical marijuana patients from federal prosecution.
House Bill 689, the States’ Medical Marijuana Patient Protection Act, would ensure that medical cannabis patients in states that have approved its use will no longer have to fear arrest or prosecution from federal law enforcement agencies. It states, “No provision of the Controlled Substances Act shall prohibit or otherwise restrict in a State in which marijuana may be prescribed or recommended by a physician for medical use under applicable State law.”
The measure also calls for the federal government to reclassify cannabis so that it is no longer categorized as a Schedule I prohibited substance with no accepted medical use and a high potential for abuse. It states: “Not later than one year after the date of enactment of this Act, the Administrator of the Drug Enforcement Administration shall, based upon the recommendation under paragraph (1), issue a notice of proposed rulemaking for the rescheduling of marijuana within the Controlled Substances Act, which shall include a recommendation to list marijuana as other than a Schedule I or Schedule II.”
In January, a three-judge panel for the US Court of Appeals for the District of Columbia denied petitioners request to overturn the Obama administration’s July 2011 rejection of an administrative petition that sought to initiate hearings regarding the reclassification of marijuana under federal law.
Separate federal legislation, House Bill 710: The Truth in Trials Act, which provides an affirmative defense in federal court for defendants whose actions were in compliance with the medical marijuana laws of their state was also reintroduced this week in the US House of Representatives.
Those who wish to contact their member of Congress in support of these federal measures can do so by clicking here.
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.
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/.
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.
Scientific Review: “There Is Now Clear Evidence That Cannabinoids Are Useful For The Treatment Of Various Medical Conditions”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.”
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.