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SCIENCE

  • by NORML July 12, 2018

    Republican Gov. Mary Fallin yesterday signed into law emergency regulations amending SQ 788 — the state’s voter-initiated medical marijuana access law.

    The changes, approved Tuesday in a 5 to 4 vote by directors at the Department of Health, seek to severely limit patients’ access to a wide range of cannabis products. Specifically, the new provisions: prohibit the sale of herbal cannabis at licensed dispensaries; require dispensaries to have a licensed pharmacist on staff; impose arbitrary THC potency thresholds on various cannabis-infused products; and mandate that dispensary managers obtain at least four hours of continuing education training each calendar year. Qualified patients will still be permitted to grow their own medical marijuana flowers.

    The Oklahoma State Medical Association, which opposed the passage of SQ 788, lobbied for many of the amendments. Governor Fallin also was a vocal critic of the initiative campaign.

    NORML Deputy Director Paul Armentano criticized the changes. “Government officials are not acting in good faith. Not only are they undermining the will of the voters, but they are violating the spirit of the law in a manner that will be detrimental to the very patients this measure was intended to protect.”

    Initiative proponents are considering pursuing legal actions. Activists are also in the process of gathering signatures to place a broader, adult use legalization measure on the 2018 ballot.

    NORML has long argued that patients should not be limited solely to non-inhaled forms of cannabis because these alternative formulations possess delayed onset and their effects are far less predictable than those of herbal cannabis. Further, restricting patients’ access to herbal cannabis limits their exposure to the multitude of synergistically acting therapeutic compounds and terpenes found naturally in the plant, many of which are no longer present in formulations produced following the extraction of individual cannabinoids.

  • by Paul Armentano, NORML Deputy Director July 11, 2018

    The enactment of medical cannabis access laws is associated with significant reductions in prescription opioid use among Medicaid enrollees, according to just-published data in the journal Addiction.

    Investigators with the University of California at San Diego assessed the relationship between medical cannabis legalization and opioid use among Medicaid enrollees over a period of 21 years (1993 to 2014).

    Authors reported, “For Schedule III opioid prescriptions, medical cannabis legalization was associated with a 29.6 percent reduction in number of prescriptions, 29.9 percent reduction in dosage, and 28.8 percent reduction in related Medicaid spending.” This correlation remained after authors controlled for potential confounders, such as the establishment of prescription drug monitoring programs and variations in patients’ income.

    By contrast, authors did not report similar changes in enrollees’ use of Schedule II opioid drugs, like Oxycodone. Authors speculated that this result may be because physicians are more reticent to recommend medical cannabis options to these patients.

    They concluded: “In this study, we found that statewide medical cannabis legalization implemented in 1993-2014 in the US was associated with close to 30 percent reductions in Schedule III opioids received by Medicaid enrollees.. … It was estimated that, if all the states had legalized medical cannabis by 2014, Medicaid annual spending on opioid prescriptions would be reduced by 17.8 million dollars.”

    Their findings are similar to those of numerous other observational studies – such as those here, here, and here – finding that medical marijuana regulation is correlated with reductions in overall opioid-related use, drug spending, abuse, hospitalization, and mortality. Separate data evaluating prescription drug use trends among individual patients enrolled in state-licensed medical marijuana programs is consistent with this conclusion, finding that many subjects reduce or eliminate their use of opioids following enrollment.

    The abstract of the new study, “Medical cannabis legalization and opioid prescriptions: Evidence of US Medicaid enrollees during 1993-2014,” appears online here.

  • by NORML June 25, 2018

    Regulators at the US Food and Drug Administration today granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

    The FDA’s decision was not unexpected, as the proprietary extract formulation — developed by the British biotechnology firm GW Pharmaceuticals — had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA. It is the fourth marijuana-based medicine to receive US FDA approval — joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

    Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “The FDA’s approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis. However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford.” According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month.

    He added: “We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

    Federal agencies have 90 days to determine the scheduling of Epidiolex. The new drug is anticipated to become available to patients later this fall. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

    Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy. Dravet syndrome is estimated to effect about 1 in 40,000 people.

    Despite today’s approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”

  • by Paul Armentano, NORML Deputy Director June 5, 2018

    More than two-thirds of chronic pain patients registered to legally access medical cannabis products substitute marijuana for prescription opioids, according to data published in The Journal of Headache and Pain.

    Investigators from the United States and Canada assessed the use of medical cannabis and prescription drugs in a cohort of over 2,000 Canadian patients licensed to access marijuana products. Among those patients with a primary diagnosis of chronic pain, 73 percent reported substituting cannabis in place of opioids. Among those patients diagnosed specifically with headache/migraine, cannabis was frequently reported as a substitute for other medications – including opiates (43 percent), anti-depressants (39 percent), NSAIDS (21 percent), triptans (8 percent), and anti-convulsants (8 percent).

    “Most patients in the pain groups reported replacing prescription medications with medicinal cannabis, the most common of which were opiates/opioids across all patient groups,” authors concluded. “This is notable given the well-described ‘opioid-sparing effect’ of cannabinoids and growing abundance of literature suggesting that cannabis may help in weaning from these medications and perhaps providing a means of combating the opioid epidemic.”

    The study’s findings are consistent with those of numerous others finding that patients in medical cannabis access programs significantly reduce or eventually eliminate their use of opioid analgesics over the long-term.

    Full text of the study, “Patterns of medicinal cannabis use, strain analysis, and substitution effect among patients with migraine, headache, arthritis, and chronic pain in a medicinal cannabis cohort,” appears online here.

  • by Paul Armentano, NORML Deputy Director May 8, 2018

    Medical marijuanaPatients enrolled in New York state’s medical cannabis program reduce their use of opioids and spend less money on prescription medications, according to data published online in the journal Mental Health Clinician.

    Investigators from the GPI Clinical Research in Rochester and the University of Buffalo assessed trends in patients’ medical cannabis and prescription drug use following their enrollment into the state’s marijuana access program.

    On average, subjects’ monthly analgesic prescription costs declined by 32 percent following enrollment, primarily due to a reduction in the use of opioid pills and fentanyl patches. “After three months treatment, medical cannabis improved [subjects’] quality of life, reduced pain and opioid use, and lead to cost savings,” authors concluded.

    The study’s findings are similar to those reported among enrollees in other states medical cannabis programs, including the experiences of patients in Illinois, Michigan, Minnesota, New Mexico, and elsewhere.

    The full text of the study, “Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis,” appears online here. NORML’s fact-sheet highlighting the relevant, peer-reviewed research specific to the relationship between cannabis and opioids is available online here.

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