Sunday, June 21, 2015

Medical marijuana revisited

From the YouTube blurb:  "After taking more than 22 pills a day, this father decided that enough is enough and gave his son marijuana extract... the results are mind blowing. Another human case to back up the science."

Courtesy of a friend.

Jayden has Dravet syndrome.  See:

See also here:  Minnesota medical marijuana 3/3/15, especially:  Medical marijuana--the Colorado experience.
See also here: Don't Bogart that candy, my friend... 4/24/15
See also here: Cannabis and stroke 2/25/15


  1. Alexis Bortell is a Texas girl whose daily epileptic seizures were quelled by medical marijuana, and now she is turning into one of the state’s biggest advocates for legalized cannabis.

    One year ago, Bortell was living with a condition that prevented her from living a normal life, and treatments were not making the seizures get any better.

    A specialist told the Bortell family that Alexis might benefit by leaving Texas and moving to a state where she could be treated with medical marijuana.

    “We’ve always said if Alexis’ health or life was in danger we would leave,” her father Dean Bortell said.

    But after a serious seizure, the Bortell family decided to move to Colorado, where she responded immediately to the cannabis oil treatment.


    From June 5, 2015: ALEXIS BORTELL: Hi, I'm Alexis Bortell of Team Alexis, and I just celebrated 60 days seizure-free at Chuckie Cheese's thanks to medical cannabis.


    Also see:

  2. It’s buyer-beware for medical marijuana users, since the data supporting the benefits of cannabinoids are still in flux, and most marijuana edibles aren’t well labeled.

    There’s a big difference between anecdotal evidence and scientific proof, and the field of medical marijuana research is filled with more of the former than the latter—in part because marijuana is notoriously difficult to study because it’s classified as a schedule-1 drug.

    Scientists led by Penny Whiting from University Hospitals Bristol in the U.K. report in JAMA that there is only moderate-quality evidence supporting the benefits of medical marijuana, and only for certain conditions. The majority of studies involving medical marijuana are of lesser quality and therefore more likely to be biased and provide unreliable results.

    In all, Whiting and her colleagues analyzed 79 randomized trials, the gold standard in medical research in which volunteers are randomly assigned to take a cannabis-related product or a placebo. The studies evaluated marijuana’s ability to relieve a range of symptoms including nausea from chemotherapy, loss of appetite among HIV positive patients, multiple sclerosis spasms, depression, anxiety, sleep disorders, psychosis and Tourette syndrome. Most of the studies showed improvements among the participants taking the cannabinoid products over those using placebo, but in many, the scientists admitted that they could not be sure that the effect wasn’t simply due to chance since the association was not statistically significant...

    But medical marijuana products, he says, aren’t regulated by the same system that vets other pharmaceutical drugs. In fact, cannabinoids are not regulated at all, since the federal government still considers marijuana an illegal substance and therefore does not acknowledge that marijuana-based therapies exist at all. So far, 23 states have legislated such medicinal marijuana into legality, which means that legislation, and not scientific criteria, have “approved” these compounds for medical use. The results? “What we saw was that there cant’ be much if any consumer confidence within the cities we purchased and tested products,” says Vandrey.


  3. The first of three studies (Abstract#1.326) to be presented in full at the Annual Meeting is from Colorado, where much of the nation’s attention has been captured by issues surrounding cannabis. The physicians and researchers at Children’s Hospital Colorado and the University of Colorado have a unique perspective on CBD given the large number of cases they have treated. In addition to the many children already in their care, these professionals are now caring for many of the patients who have ventured to Colorado in search of cannabis treatment.

    Dr. Kevin Chapman, associate professor of pediatrics and neurology at the University of Colorado, and his colleagues conducted a retrospective review of the 58 children and adolescents (average age of 7) who had catastrophic forms of epilepsy and were receiving artisanal oral cannabis extracts when they came under the care of the hospital-based team. Chapman’s team found that in only one-third of patients did the parents report a seizure reduction of 50% or more, and this did not correlate with an improvement in their electroencephalograms (EEGs). Of the sixteen patients who had baseline EEGs prior to and during treatment with cannabis, only two showed any signs of improvement. The researchers also noted that the response rate did not change with various strains of cannabis. Notably, families who moved to Colorado for CBD treatment were three times as likely to report a reduction greater than 50% than families who were already in Colorado.(Continued)

  4. (Continuation) Adverse effects occurred in 47% of patients, with increased seizures or new seizures in 21%, somnolence/fatigue in 14%, and rare adverse events of developmental regression in 10% with one patient needing intubation, and one death.

    “This substantial gap between the clinical observations and various anecdotal reports highlighted in popular media underscores the desperate need shared by the entire epilepsy community for robust scientific evidence regarding the potential benefit and risks of marijuana in people with epilepsy,” said Dr. Chapman.

    Two additional studies that will be featured at the Annual Meeting provide updates on the development of Epidiolex (GW Pharmaceuticals), a purified and formulated form of CBD. The first study (Abstract #3.303) explores initial data from an efficacy and safety study, a precursor to a randomized clinical trial. Twenty-three patients with treatment-resistant epilepsies, especially Dravet Syndrome, with an average age of 10, were enrolled in two sites at New York University and the University of California San Francisco. After establishing a 4-week baseline of frequency, type of seizures and existing antiepileptic drug (AED) regimes, patients received a purified 98% oil-based CBD extract, of known and constant composition at a dose of 5mg/kg/day in addition to their baseline AED regimen. The daily dose was gradually increased until intolerance occurred or a maximum dose of 25 mg/kg/day was achieved. After three months of therapy, 39% of patients had a greater than 50% reduction in seizures with a median reduction of 32%. Seizure freedom occurred in 3/9 Dravet patients and 1/14 patients with other forms of epilepsy. Adverse effects were mostly mild or moderate and included somnolence, fatigue, AED level increases, decreased appetite, weight gain, diarrhea, increased appetite and weight loss.

    "These results are encouraging, especially since they involved a group of children and young adults with very treatment-resistant epilepsy. However, we await the planned double-blind study to truly assess the safety and efficacy of Epidiolex,” said Orrin Devinsky, M.D., director of the NYU Comprehensive Epilepsy Center and professor of neurology, neurosurgery and psychiatry at the NYU School of Medicine.

    The second abstract related to Epidiolex (Abstract #2.309) examined the drug interactions between existing AEDs and the CBD extract Epidiolex. In this study, 33 patients (with an average age of 10) were taking an average of three different AEDs including clobazam (54.5% of patients), valproate (36.4%) and levetiracetam (30.3%), felbamate (21.2%), Lamotrigine (18.2%) and zonisamide (18.2%). Baseline AED concentrations were established and then taken again after the addition of CBD. Patients were given a purified 98% CBD extract, of known and constant composition at a dose of 5mg/kg/day in addition to their baseline AEDs. The study found that in patients on multiple AEDs, the addition of CBD may be associated with changes in serum concentrations of some concomitant AEDs. A subset of patients experienced an increase in clobazam concentrations requiring a dose adjustment and suggesting CBD’s effects on the major metabolic pathway of clobazam.


    “These results support experimental findings that CBD can affect metabolism of some common anti-epileptic drugs though the effects may not be seen in all patients. More studies are needed to understand the potentially complex interactions between CBD and other drugs but in the meantime, frequent monitoring of drug levels is warranted in children taking CBD-containing products, including medicinal cannabis,” Daniel Friedman, M.D., epileptologist and a clinical neurophysiologist at the NYU Comprehensive Epilepsy Center.


  5. With many US states now having laws in place to facilitate access to medical marijuana for a variety of medical conditions, two new reviews have highlighted the lack of evidence to support its use in most indications.

    An editorial also raises questions about the legal implications for doctors prescribing such products.

    The reviews, published in the June 23/30 issue of JAMA, note that 23 states and the District of Columbia have enacted laws to allow prescription of medical marijuana for certain medical conditions.

    Reviewing the medical literature on medical marijuana, the two papers come to similar conclusions — that some evidence supports the use of marijuana for nausea and vomiting related to chemotherapy, specific pain syndromes, and spasticity from multiple sclerosis. But for most other indications such as hepatitis C, Crohn's disease, Parkinson's disease, or Tourette's syndrome, they found that the evidence supporting its use is of poor quality.

    A third paper in the same issue of JAMA highlights the large variability in specific cannabinoids in various medical marijuana products and finds that contents did not conform to what was advertised on the labelling.

    In an accompanying editorial, Deepak Cyril D'Souza, MBBS, and Mohini Ranganathan, MD, Yale University School of Medicine, New Haven, Connecticut, note that for most of the conditions that qualify for medical marijuana use, the evidence fails to meet US Food and Drug Administration (FDA) standards.

    They call for government support to conduct high-quality trials. Until such trials are available, they suggest it may be prudent to wait before widely adopting use of marijuana. "Perhaps it is time to place the horse back in front of the cart," they conclude....

    They emphasize that the prescription, supply, or sale of marijuana is illegal by federal law, and it is not known to what extent a physician who certifies a patient for medical marijuana may be liable for negative outcomes, and whether malpractice insurance will cover any liability...

    Both reviews report an increased risk for short-term adverse effects, including dizziness, dry mouth, nausea, fatigue, somnolence, euphoria, vomiting, disorientation, drowsiness, confusion, loss of balance, hallucination, addiction, and worsening of psychiatric illnesses, such as anxiety and mood disorders...

    For the dosing paper, a team led by Ryan Vandrey, PhD, Johns Hopkins University School of Medicine in Baltimore, Maryland, report that of 75 products purchased (47 different brands), 17% were accurately labeled, 23% were underlabeled, and 60% were overlabeled with respect to tetrahydrocannabinol content...

    They also point out that marijuana is a complex of more than 400 compounds, including up to 70 cannabinoids that have individual or interactive effects, and that the composition of cannabis preparations can vary substantially...

    Given that cannabinoid exposure during critical periods of brain development is associated with long-lasting changes in behavior and cognition, they say careful consideration is needed to determine at what age exposure to medical marijuana is justifiable.


  6. References to above entry

    D'Souza DC, Ranganathan M. Medical Marijuana: Is the Cart Before the Horse?
    JAMA. 2015 Jun 23-30;313(24):2431-2.

    Hill KP. Medical Marijuana for Treatment of Chronic Pain and Other Medical and
    Psychiatric Problems: A Clinical Review. JAMA. 2015 Jun 23-30;313(24):2474-83.

    Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV,
    Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73.

  7. A 16 yo adolescent experienced a first seizure. As part of his emergency Department assessment, a urine toxicology screen was obtained, which was positive for cannabanoids. Evidently, in this n=1, prophylaxis was ineffective.

  8. A new study claims that a component in cannabis may help heal broken bones, but that doesn't mean you should smoke a joint the next time you find yourself in a cast or on crutches.

    Researchers at Tel Aviv University concluded that cannabidiol (CBD), a liquified non-psychotropic component of the cannabis plant, makes broken bones heal stronger. But their study was small, and it wasn't in humans; it was in a couple dozen rats.

    The results are preliminary at best, experts say.

    "Insofar as these studies go, it's not the worst I've seen, but the numbers are, I would say, on the low side," said Jeffrey Nyman, PhD, of the Vanderbilt Center for Bone Biology.

    The study was published in the Journal of Bone and Mineral Research and has generated such pun-tastic headlines as "No Bones About It: Cannabis May be Used To Treat Fractures" and "Joint Relief: Marijuana Helps Mend Broken Bones."

    But lead study author Yankel Gabet, DMD, PhD, of Tel Aviv University in Israel, said it's not clear how CBD heals bones in rats, let alone whether it would work in humans.

    "The main limitation is that this is the very first study on the matter and results have been obtained in animals only," Gabet said....

    Margaret Gedde, MD, who has treated only medical marijuana patients since 2009 at her private practice in Colorado, said Gabet's study is a good example of a basic animal study to pave the way for an eventual human study, but it's not enough to draw conclusions for the future of fracture care.

    "It would be a big leap to then conclude that CBD in a person, at a certain dose or used in a certain way, will help their bones heal," she said. "Animals are not people. But, the study does lay new ground and points to the possibility that CBD in some form might be used to help bone healing in people."

  9. It's early days, but a Hibbing couple are ecstatic about their daughter's initial response to treatment with medical marijuana.

    "We gave her her first dose on Friday morning," Angie Weaver said on Monday about 9-year-old daughter Amelia. "She had a seizure-free day."

    Amelia, who has Dravet syndrome, a rare and catastrophic form of epilepsy, had been suffering between 30 and 80 drop seizures per day, her mother said. In a drop seizure, the individual temporarily loses muscle strength and often falls without any ability to catch herself.

    Although she was able to walk and say her ABCs and count to 20 at age 2½, the Dravet syndrome then robbed Amelia of her ability to speak or to perform such basic tasks as eating with a fork and spoon. Her development regressed.

    Amelia had no seizures on Friday and none on Saturday, Angie Weaver said. As of Monday afternoon, she had had a total of two seizures since starting to take the medicine...

    Amelia takes three doses a day. It's mixed with coconut oil and dispensed through a dropper, and the taste seems to be acceptable. "Amelia didn't make a face," Angie said.

    The early benefits have gone beyond the lack of seizures.

    "You can look at her now, and she's focusing for the first time since she started having seizures," Angie said. "She's looking at you in the eye. ... Her body has calmed down. She's starting to smile. It's amazing."...

    For the Weavers, another benefit is sleep, not just for Amelia but for parents Josh and Angie.

    Since starting on the medical marijuana regimen, Amelia has slept as much as five hours at a time, her mom said. That may not sound like much, but she previously never slept more than two hours at a time. It's a common aspect of Dravet syndrome, Angie explained.

    "This last year it's been the worst it's ever been," she said. She and Josh take turns caring for Amelia when she's awake at night, she said.

    "We've not as a family had very much sleep in nine years."

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