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SCIENCE

  • by Paul Armentano, NORML Deputy Director May 26, 2020

    Marijuana researchThe delivery of precise doses of THC via an inhaler is associated with pain mitigation in patients with neuropathy and other complex pain conditions, according to clinical trial data published in the European Journal of Pain.

    A team of Israeli researchers conducted a randomized placebo-controlled clinical trial to assess the safety and efficacy of a novel, metered-dose cannabis inhaler in 27 patients with chronic pain. Participants inhaled a precise dose containing either THC (at doses of either 0.5mg or 1mg) or placebo.

    They reported: “Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-minutes. The 1mg dose showed a significant pain decrease compared to the placebo. Adverse events were mostly mild and resolved spontaneously. There was no evidence of consistent impairments in cognitive performance.”

    Authors concluded: “This feasibility trial demonstrated that a metered-dose cannabis inhaler delivered precise and low THC doses [that] produced a dose-dependent and safe analgesic effect in patients with neuropathic pain/complex-regional pain syndrome (CRPS). Thus, it enables individualization of medical cannabis regimens that can be evaluated pharmacokinetically and pharmacodynamically by accepted pharmaceutical models.”

    Prior clinical trials, such as those here and here, have similarly reported that a metered-dose inhaler can deliver precise therapeutic doses of cannabis to pain patients absent any significant adverse effects.

    Chronic pain is the most commonly reported qualifying condition among medical cannabis patients enrolled in state-specific access programs. A 2017 literature review by the National Academy of Sciences, Engineering, and Medicine concluded, “There is conclusive or substantial evidence that cannabis or cannabinoids are effective for the treatment of chronic pain in adults.”

    An abstract of the study, “Pharmacokinetics, efficacy, and safety of a novel selective-dose cannabis inhaler in patients with chronic pain: A randomized, double-blinded, placebo-controlled trial,” is online here. Additional information regarding cannabinoids and pain appears online here.

  • by Paul Armentano, NORML Deputy Director May 19, 2020

    Legalize MarijuanaThe enactment of adult-use cannabis legalization laws in Colorado and Washington is associated with increased tourism in both states, according to data published in the Journal of Regional Analysis & Policy.

    A team of researchers affiliated with Berry College in Georgia compared rates of hotel occupancy in Colorado and Washington post-legalization as compared to trends in other non-legal states.

    Authors reported a “large increase in hotel rooms rented in Colorado” immediately following legalization. Washington state also experienced an uptick, but it was not as significant. Both states experienced their highest jumps in tourism following the advent of retail cannabis sales.

    “[L]egalization in Colorado is associated with an increase of nearly 51,000 hotel rooms rented per month [and] once commercial sale is permitted, there is an increase of almost 120,000 room rentals per month,” authors determined. In Washington, increases were approximately half that total.

    Authors concluded: “Marijuana legalization led to a larger increase in tourism in Colorado than Washington. One possible explanation is that Colorado is an easier travel destination than Washington. … Another possible explanation is that Colorado may have achieved a first mover advantage over Washington since it legalized commercial sale six months earlier than Washington. A third possible explanation is that Washington is adjacent to British Columbia which has a strong reputation for growing marijuana and a laid-back attitude toward marijuana consumption (though use remains illegal). While marijuana legalization increased tourism, especially in Colorado, the benefit may wane as additional states including California, Michigan, and Illinois, legalize the possession and sale of marijuana.”

    Survey data commissioned by the Colorado Tourism Office has previously reported that nearly half of all tourists who visit the state are motivated do so because of Colorado’s liberal marijuana policies.

    The full text of the study, “The effect of marijuana on hotel occupancy in Colorado and Washington,” is online here. Additional information appears in the NORML fact-sheet, “Marijuana Regulation: Impact on Health, Safety, and Economy.”

  • by NORML April 8, 2020

    The National Organization for the Reform of Marijuana Laws (NORML) has formally submitted comments to the US Federal Register opposing the Drug Enforcement Administration’s proposed rule changes governing the federal production and distribution of cannabis for clinical research purposes.

    Under existing regulations, the agency only licenses one facility — the University of Mississippi — to cultivate cannabis for use in FDA-approved clinical trials. Researchers have consistently criticized the poor quality of these plants, which they say fail to accurately reflect the varieties of marijuana commercially available in the United States. As a result, the DEA has been encouraged for over a decade to expand the pool of federally licensed cannabis producers — a move that the agency has largely resisted.

    In 2016, the agency appeared to reconsider its longstanding policy, and publicly stated for the first time that it would consider additional applicants. To date, however, the DEA has failed to either affirm or reject any of the more than 30 applications it has received. Under the proposed rules issued by the DEA on March 23, the agency continues to maintain sole discretion to decide which applicants, if any, will be permitted to grow cannabis for research purposes, and it provides no timeline under which the DEA must act on the numerous applications already before it.

    In its response to the DEA’s proposed changes, NORML writes: “While NORML has long supported facilitating and expanding domestic clinical research efforts, we do not believe that these proposed rules, if enacted, will achieve this outcome. Rather, we believe that the adoption of these rules may further stonewall efforts to advance our scientific understanding of cannabis by unduly expanding the DEA’s authority and control over decisions that ought to be left up to health experts and scientists.”

    Specifically, the newly proposed rules expand the DEA’s authority by declaring it to be the only entity legally permitted to purchase, warehouse, and dispense any cannabis grown under a federal license.

    NORML’s response concludes: “Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, NORML believes that federal regulators should allow investigators to access the cannabis that is currently being produced by the multitude of state-sanctioned growers and retailers throughout the country. … Doing so would not only facilitate and expedite clinical cannabis research in the United States, but it would also bring about a long overdue end to decades of DEA stonewalling and interference with respect to the advancement of our scientific understanding of the cannabis plant.”

    An abbreviated version of NORML’s comments appears here.

    ON BACKGROUND: The DEA has consistently discouraged the scientific investigation of cannabis, particularly with respect to its therapeutic properties.

    * In 1988 the agency’s own administrative law judge concluded marijuana to be “one of the safest therapeutically active substances known to man,” and demanded the DEA reclassify the plant so that doctors could prescribe it. The agency set aside the decision and refused to act upon the judge’s order.

    * In 2007, the agency lost yet another lawsuit. In this case, the judge ruled that there existed an “inadequate supply of marijuana available for research purposes,” and therefore determined that permitting the privately licensed production of cannabis for research purposes would be “in the public interest.” Once again, the agency set aside the decision and refused to abide by the judge’s ruling.

    * in 2016, the agency enacted a revised set of rules explicitly designed to expand the pool of applicants eligible to cultivate cannabis for use in FDA-approved clinical protocols. Following the issuance of these new rules, dozens of proprietors — including branches of the University of California and the University of Massachusetts — applied to the agency seeking licensure. But to date, the agency has neither accepted nor denied a single applicant.

  • by NORML April 7, 2020

    VaporizerIncidences of the vaping-related lung illness EVALI (e-cigarette or vaping product use-associated lung injury) are primarily concentrated to jurisdictions where adult-use cannabis consumption is prohibited, according to data published in the Journal of the American Medical Association (JAMA) Network Open.

    Commenting on the findings, NORML Executive Director Erik Altieri said, “These findings come as little surprise. In jurisdictions where cannabis is legally regulated, consumers gravitate toward the above-ground retail marketplace where they can access lab-tested products manufactured by licensed businesses.” He added, “Just like alcohol prohibition gave rise to the illicit production of dangerous ‘bathtub gin,’ marijuana prohibition provides bad actors, not licensed businesses, the opportunity to fulfill consumers’ demand – sometimes with tragic results.”

    According to the US Centers for Disease Control and Prevention, nearly 3,000 people have sought hospitalization because of the illness, which peaked last September, and nearly 70 people died as a result of it. In November, the CDC publicly identified vitamin E acetate – a diluting agent sometimes present in counterfeit, unregulated vape pen products – as a primarily “culprit” in the outbreak.

    Writing on Monday in the journal JAMA Network Open, researchers affiliated with Indiana University reported that last year’s sudden outbreak of EVALI cases was not driven by either state-level differences or prevalence in e-cigarette use. Rather, they reported that cases “were concentrated in states where consumers do not have legal access to recreational marijuana dispensaries. … One possible inference from our results is that the presence of legal markets for marijuana has helped mitigate or may be protective against EVALI.”

    A previous analysis of EVALI prevalence in legal cannabis markets versus illegal markets by Leafly.com drew a similar conclusion.

    In a statement to the online news site MedPageToday.com, the study’s lead author said that the team’s findings are “consistent with the hypothesis that people have demand for marijuana products, and in states where they don’t have access to them in this regulatory fashion, they end up purchasing them elsewhere.”

    Full text of the study, “Association of state marijuana legalization policies for medical and recreational use with vaping-associated lung disease,” appears in JAMA Network Open. An accompanying editorial, “Marijuana legislation and electronic cigarette- or vaping-associated lung injury,” also appears online here.

  • by Paul Armentano, NORML Deputy Director March 30, 2020

    There is an absence of clinical data supporting the efficacy of CBD as an antiviral agent, according to a systematic literature review published in the journal Cannabis and Cannabinoid Research.

    A team of researchers from Italy and the United Kingdom performed a systematic review of peer-reviewed papers specific to the application of CBD in viral diseases. They reported “circumstantial evidence” suggesting that CBD may possess antiviral activity in a limited number of conditions, specifically in the treatment of hepatitis C and Karposi sarcoma. However, this data was based solely on preclinical findings. By contrast, they reported that there exists “no evidence from properly designed clinical trials to support the use of CBD for the treatment” of these or other conditions, such as the flu, West Nile virus, Ebola, or common cold viruses.

    Yet, despite this lack of clinical data, authors identified numerous commercial websites touting CBD as a clinically beneficial antiviral agent. They reported, “Claims about the benefits of using CBD on viral infections were largely supported by CBD online retailers and most often appear to be a biased interpretation of the scientific literature or a dishonest manipulation of the information for commercial purposes.”

    They concluded: “CBD sellers should stop promoting claims that are not backed by scientific evidence. Misleading claims represent both a threat to public health and a violation of consumer access to accurate information.”

    In recent days, NORML has issued multiple warnings cautioning people to beware of online misinformation surrounding the use of either whole-plant cannabis or CBD as a potential remedy for the COVID-19 virus. Specifically, NORML Executive Director Erik Altieri has stated: “If something sounds too good to be true, it likely is. During these difficult times, we encourage people to be skeptical of any unsubstantiated claims, particularly those circulating online, surrounding the use of cannabis or any other uncorroborated treatment for COVID-19.”

    The full text of the study — entitled “Cannabidiol for viral diseases: Hype or hope?” — appears online here. Additional information regarding cannabis, CBD, and COVID-19 is available from Project CBD here.

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