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CBD

  • by Keith Stroup, NORML Legal Counsel June 17, 2014

    Most of us were caught off-guard by the rush of states this year that approved the limited use of CBD-only marijuana extracts because these traditionally conservative states had heretofore rejected the medical use of marijuana. So it seems worth a moment to consider how this occurred, and what it means on a grander scale.

    But first, a little recent history.

    Throughout this year’s state legislative season, a total of 10 states enacted laws seeking to provide limited access to medical marijuana products that contain high levels of CBD and virtually no THC for qualified, typically pediatric patients suffering from severe and disabling seizures: Alabama, Florida, Iowa, Kentucky, Mississippi, Missouri, South Carolina, Tennessee, Utah and Wisconsin.

    On one level, this unexpected embrace of the medicinal qualities of marijuana by states that previously rejected the concept must be seen as a favorable development. These serendipitous adoptions reflect a degree of compassion not obvious in the previous legislative debates in those states.

    But it is far from certain that these laws will actually help the young patients they are intended to help.

    First, such products are primarily only available in a handful of states like California and Colorado and none of these new state laws create a viable in-state supply source for such products. Further, even if a patient from out-of-state could find these products in California or Colorado, it would be a violation of federal law (and also likely state law) to take the medicine back to their home state.

    And while some of these laws attempt to establish CBD research projects at their major universities or research hospitals, recent experience demonstrates that few universities or research hospitals are willing to enter this confusing field while marijuana remains a federal crime, and those that may be willing to take the bait will face a steep and long learning curve before the first patient will have high-CBD extracts available.

    This legislative rush to CBD-only extracts also suggests (1) the degree to which elected officials are influenced by popular media, (2) their willingness to pick and choose the science they like (while ignoring the science they do not), and (3) the strong puritanical impulse that remains a factor with many elected officials.

    And it all relates to the “Gupta Effect”. When CNN’s Dr. Sanjay Gupta’s report highlighting how high-CBD marijuana products control debilitating seizures among children suffering from Dravet’s syndrome (the most severe form of childhood epilepsy) went public, few Americans had even heard of cannabidiol. Most people were familiar with THC (tetrahydrocannabinol), the primary psychoactive ingredient in marijuana that principally accounts for the “high” that marijuana smokers enjoy, but had zero idea that CBD even existed.

    Dr. Gupta, who had previously uncritically accepted the federal government’s consistent claim that marijuana had no legitimate medical use, when confronted with actual children whose lives had been transformed following their use of high-CBD marijuana extracts, understandably felt misled by the government’s anti-marijuana propaganda, and went public with two special programs introducing the importance of high-CBD extracts in reducing or eliminating seizures in these children.

    In the second program Dr. Gupta made it clear that while CBD appeared to be the primary therapeutic ingredient for this class of patients, he also made the point that some level of THC was also required, because of what he termed the “entourage effect.” Without the THC, the CBD would either be less effective, or in some instances ineffective.

    It’s embarrassing that so many of our elected officials would get their scientific understanding of the medical properties of marijuana from a popular television doctor, instead of conducting their own research into the available science, before moving legislation forward. But better they be motivated by a celebrity doctor than continue to ignore the benefits of medical marijuana altogether.

    Of which there are a myriad.

    The marijuana plant is one of the most studied biologically active substances of modern times. A search on PubMed, the repository for all peer-reviewed scientific papers, using the term “marijuana” yields nearly 20,000 scientific papers referencing the plant and/or its constituents, nearly half of which have been published just within the past decade. In addition, more than 100 controlled trials, involving thousands of subjects, have evaluated the safety and efficacy of cannabis and/or individual cannabinoids.

    Most recently, a review of FDA-approved marijuana plant trials conducted by various California universities concluded, “Based on evidence currently available the Schedule I classification (for cannabis) is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.” The best summary of this research can be found in the publication Emerging Clinical Applications for Cannabis and Cannabinoids, available on the NORML website. So the basic research is available for all who care to learn.

    But few elected officials appear to be aware of this considerable body of science. Rather, the common refrain is to claim they cannot support the medical use of marijuana because the only evidence is “anecdotal”. These officials prefer to remain ignorant because it reinforces their preconceived notion that medical marijuana is a hoax perpetuated by those who simply wish to get “high”.

    So what this latest rush to approve CBD-only marijuana products demonstrates, more than anything else, is the degree to which our public policy can frequently be influenced by a strong strain of puritanism that remains alive among our elected officials. If it feels good, it must be bad!

    These many state legislators were willing to show some compassion by allowing the medical use of marijuana by these poor children suffering from multiple, disabling seizures, so long as the marijuana did not make them feel “high” (i.e., feel better!). These legislators are against pleasure, and if the use medical marijuana includes the feeling of pleasure, then it cannot be approved.

    Excuse me, but is that not the purpose of using medicine when one is ill – to feel better?

    Admittedly, for some of these puritans, the association of the word “high” with the use of marijuana may lie at the heart of the problem for them. Marijuana has long been demonized by conservatives, law enforcement, and many in the medical community, and that has spilled-over to the marijuana “high”.

    If they understood that the marijuana “high” makes the user feel better, and that seriously ill patients almost always want (and need) to feel better, perhaps they could overcome their fear of medical marijuana. But for now at least, it is clear that in their view the marijuana “high”, like marijuana itself, is something to be avoided by responsible Americans, even if that precludes the use of medical marijuana by seriously ill patients.

    It is time we moved beyond the notion that pleasure is bad, and stopped treating the marijuana “high” as something to be avoided, when it makes patient feel better. For them, feeling better and feeling high is often the same.

  • by Paul Armentano, NORML Deputy Director April 10, 2014

    Lawmakers in Alabama and Utah recently approved legislation seeking to authorize the physician-supervised use of varieties of cannabis and/or extracts high in the non-psychotropic cannabinoid cannabidiol (CBD). Both measures, which I previously summarized as ‘largely unworkable,‘ have now been signed into law.

    In recent days, lawmakers in three additional states — Kentucky, Mississippi, and Wisconsin — have similarly signed off on CBD-explicit legislation. These measures are now awaiting signatures from each states’ respective Governors.

    Similar to Alabama’s SB 174 (aka ‘Carley’s Law), which only permits the use of CBD by prescription during the course of an FDA-approved clinical trial, the pending Kentucky and Wisconsin bills may also be classified as ‘research-centric’ measures. Kentucky’s SB 124 permits physicians “practicing at a hospital or associated clinic affiliated with a Kentucky public university” to “dispense” cannabidiol during the course of an FDA-approved clinical trial. Wisconsin’s AB 726 similarly limits those who may legally dispense CBD to only include those physicians who have obtained an FDA-issued investigational drug permit to prescribe it. In Tennessee, lawmakers are also close to finalizing similar language (included in HB 2461 and SB 2531) that seeks to allow university clinical researchers to “manufacture” and “dispense” high-CBD cannabis oil “as part of a clinical research study on the treatment of intractable seizures.” (By contrast, separate, broader medical cannabis measures seeking to authorize the use of the whole plant failed this year in all three states.)

    As I’ve previously written here and here, it is unlikely that specific changes in state law will stimulate these type of proposed clinical trials from taking place in these states any time soon. Because CBD is acknowledged by federal regulators to be classified as a schedule I prohibited substance, multiple federal agencies — including the FDA, DEA, NIDA (US National Institute of Drug Abuse), and PHS (Public Health Service) must all sign off on any clinical investigation of the cannabinoid — a process that typically takes several years. A keyword search of FDA-approved clinical trials using the terms “cannabidiol” and “United States” yields fewer than ten ongoing human trials involving CBD — less than half of which are assessing its potential therapeutic application. (Two additional safety trials assessing the use of GW Pharmaceutical’s patented high-CBD formulation Epidiolex in children with severe epilepsy are also ongoing.)

    Unlike the above-mentioned measures, Mississippi’s HB 1231, does not seek to encourage state-sponsored clinical trials. Rather, the measure exempts specific high-CBD formulated oils “that contain more than fifteen percent cannabidiol [and] … no more than one-half of one percent of tetrahydrocannabinol” from the state’s definition of a schedule I prohibited substance. However, like Utah’s HB 105 (aka ‘Charlee’s Law), Mississippi’s pending law does not provide guidance as to where patients could legally obtain such extracts. Though such high-CBD products are presently available in a limited number of medical cannabis states (such as in California and Colorado), these extracts are typically only available to in-state residents who possess authorization from a physician licensed to practice in that state. (Although Colorado state law also allows for a recreational cannabis market, which may be legally accessed by out-of-state residents, at present time such high-CBD concentrates are seldom available at retail outlets.)

    Additional cannabidiol-specific measures also remain pending in Florida and South Carolina, among other states. NORML will report on these measures as they progress and we will continue to express caution in regards to their practical utility for those patients who require immediate access to whole-plant cannabis and its variety of naturally-occurring compounds.

  • by Paul Armentano, NORML Deputy Director March 25, 2014

    At a public signing ceremony today, Utah’s Republican Gov. Gary Herbert will approve House Bill 105 — aka “Charlee’s Law.” The law, and others like it, ostensibly allows children with treatment-resistant pediatric epilepsy access to extracts of the marijuana plant high in the cannabinoid cannabidiol (CBD).

    While some media outlets are reporting that the passage of these measures are akin to ‘approving medical marijuana,’ such claims are far from accurate.

    Specifically, Utah’s HB 105 — which takes effect on July 1 — is largely unworkable. As written, the law only exempts from state prosecution those with “intractable epilepsy” who possess a cannabis extract that contains more than 15 percent CBD and no more than 0.3 percent THC. Patients must receive a written recommendation from a Utah board certified neurologist and be registered with the state Department of Health before seeking such extracts, which for the time being may only be procured from outside of the state. The extracts must be produced in a lab that possess a state-license to manufacture such products.

    While this language may appear to allow Utah patients to procure CBD products in neighboring medical cannabis states like Colorado, the likelihood of this scenario is highly doubtful. Colorado’s medical marijuana law only allows those who are state residents and who possess a state-issued patient identification card to legally purchase such products. In other words, Utah parents would have to violate Colorado law to obtain high-CBD extracts (which are likely to only be available from a medical dispensary, not a retail cannabis market). Colorado medical marijuana dispensaries would also be in violation of not just the letter of the law, but also the spirit of the law by providing a product they know is intended to be transported across state lines — a clear violation of the guidelines put forward in the August 2013 Department of Justice memo which call for “preventing the diversion of marijuana from states where it is legal in some form to other states.”

    Utah’s forthcoming law also calls on the state Department of Agriculture “to grow or cultivate industrial hemp for the purpose of
    agricultural or academic research,” ostensibly for the purpose of one-day producing high-CBD cannabis medicines. However, it remains to be seen whether such industrial crops can yield therapeutically effective CBD extracts or whether federal lawmakers would even allow such a state-sponsored research project to move forward.

    In Alabama, members of the House and Senate unanimously approved CBD-specific legislation, Senate Bill 174 aka “Carley’s Laws,” late last week. Republican Gov. Robert Bently has announced his intent to sign the measure into law.

    However, like the Utah law, Alabama’s forthcoming law will also be largely unworkable for those who seek to benefit from it. The measure appropriates $1 million dollars for University of Alabama-sponsored research in CBD extracts. Whether such research will actually take place is another story. Because CBD is, like the cannabis plant itself, classified under federal law as a schedule I controlled substance, multiple federal agencies — including the FDA, DEA, NIDA (US National Institute of Drug Abuse), and PHS (Public Health Service) must all sign off on any clinical investigation of the drug — a process that typically takes several years and often ends with federal regulators rejecting the protocol outright. Yet, under “Carley’s Law,” patients may only legally access CBD under if it is “prescribed” during the course of such a federally approved clinical trial.

    Nevertheless, despite these obvious limitations in implementation, lawmakers in various other states — including Florida, Kentucky, Minnesota, South Carolina, and Wisconsin — are considering passing similar measures. (A similar Georgia measure died when lawmakers adjourned late last week.) While the passage of these measures may pose symbolic victories for legislators, they fail to provide tangible benefits to the constituents that they are intended to serve.

  • by Paul Armentano, NORML Deputy Director March 19, 2014

    Lawmakers in four states — Alabama, Georgia, Kentucky, and Utah — are poised to enact legislation in the coming days/weeks aimed at providing patients, primarily children with forms of intractable epilepsy, with strains of cannabis and/or cannabis extracts high in the compound cannabidiol (CBD).

    I have previously written why, in theory, these proposals will likely provide only limited relief for patients. A closer look at the text of these proposed laws indicates that, in fact, they are largely unworkable and will most likely provide no tangible relief or protection for the patient community they are intended to serve.

    Excerpt via Alternet.org. (Read the entire article here.)

    Alabama: Senate lawmakers unanimously approved SB 174, aka “Carley’s Law,” which seeks to allow investigators at the University of Alabama to study CBD in FDA-approved trials. But no change in state law is actually necessary to permit state university researchers to conduct clinical trials on cannabidiol. Such FDA-approved protocols are already permitted under federal law, but they require the added approval of regulators at the DEA, NIDA (National Institute on Drug Abuse), and PHS (Public Health Service). However, since CBD (like marijuana) is classified as a Schedule I substance under federal law, these agencies have historically been reticent to allow such studies to go forward, a fact that will likely remain unchanged even if House members similarly sign off on Carley’s Law.

    Georgia: A Senate panel last week amended and approved House Bill 885, aka “Haley’s Hope Act.” …The amended Senate plan … only provides for an exemption from state prosecution for those who obtain CBD oil from a legal medical marijuana state and transport it back to Georgia. In theory, this would allow Georgia parents to visit a state like Colorado to obtain medicine for their children. But in practice, Colorado’s medical marijuana law only allows those who are state residents and who possess a state-issued patient identification card to legally purchase such products. In other words, Georgia parents would have to violate Colorado law to obtain CBD-oils (which are likely to only be available from a medical dispensary, not a retail cannabis market). Colorado medical marijuana dispensaries would also be in violation of not just the letter of the law, but also the spirit of the law by providing a product they know is intended to be transported across state lines—a clear violation of the guidelines put forward in the August 2013 Department of Justice memo which call for “preventing the diversion of marijuana from states where it is legal in some form to other states.”

    Kentucky: Senators last week gave unanimous approval to Senate Bill 124. Like Alabama’s proposal, the bill calls on University of Kentucky researchers to study CBD in clinical trials — something they could do with or without passage of a new state law, if the necessary federal agencies agreed to it. The measure also seeks to allow physicians at state teaching hospitals to recommend CBD to patients. However, past experience from other states indicates that this latter scenario is unlikely. In 2013, Maryland lawmakers enacted legislation to allow physicians at the state’s limited number of teaching hospitals to dispense cannabis. To date, no Maryland hospitals have taken up the state’s invitation to do so.

    Utah: House and Senate lawmakers have given final approval to House Bill 105. Utah’s governor is expected to sign the measure into law imminently. Like Georgia’s proposal, the Utah measure, which sunsets in 2016, provides protection from state prosecution for parents who can acquire CBD-oil for their epileptic children, assuming a neurologist has authorized the treatment. But, as will be the case in Georgia, Utah patients will likely only be able to obtain CBD from out of state, an act that would violate neighboring states’ medical cannabis laws. The Utah proposal also calls on the state Department of Agriculture to grow industrial hemp for the purposes of one day producing cannabis medicines. However, it remains to be seen whether such industrial crops can yield therapeutically effective CBD-extracts or whether federal lawmakers would even allow such a state-sponsored research project to move forward.

  • by Paul Armentano, NORML Deputy Director March 6, 2014

    In recent weeks, lawmakers in several states have moved forward with legislative proposals to permit specific strains and/or extracts of cannabis possessing high quantities of the cannabinoid cannabidiol (CBD), but otherwise maintaining criminal prohibitions on the whole plant.

    But is this new direction in the best interest of patients? As I wrote in a recent column for Alternet.org (republished with permission by Cannabis Now under the title “Patients Ought To Be Skeptical Of Proposed CBD-Only Legislation — Here’s Why”), I believe the answer is ‘no.’

    Ultimately, patients should not be unnecessarily forced to decide between either accessing the whole plant or its isolated components. They should have safe, legal access to both, and politicians, even well-intentioned ones, should not restrict patients’ right to choose the most suitable option.

    Below are excerpts from my commentary. You can read the entire text here.

    Patients Ought To Be Skeptical Of Proposed CBD-Only Legislation — Here’s Why
    via Cannabis Now

    [excerpt] If the plant ain’t broke, why fix it?

    For longtime marijuana law reformers, the ongoing political conversation surrounding CBD is instructive. It makes it clear that many politicians’ public opposition to the idea of patients using marijuana therapeutically isn’t because of supposed unanswered questions surrounding the plant’s safety or efficacy. Rather, it is because lawmakers oppose the idea of some people getting high from a naturally growing herb. (The fact that patients can get equally high or even higher from FDA-approved synthetic THC has, for whatever reason, never been an expressed concern of either lawmakers or prohibitionists.) After all, the very same politicians who argue that marijuana isn’t medicine because it hasn’t been approved by the FDA or who allege that the substance hasn’t yet been subjected to sufficient scientific scrutiny utter no such public objections to the idea of legalizing patient access to CBD – a schedule I compound that hasn’t been reviewed, much less approved by the FDA, and that has been clinically studied far less than cannabis.

    Perhaps most ironically is that were it not for the advent of legalized whole plant marijuana, a policy change publicly opposed by many present day CBD-only political advocates, lawmakers (and anti-pot groups like SAM) today wouldn’t be aware of CBD, much less advocating for it. The reality is that it was the stakeholders in medical marijuana states, and those who provide for them, who have done the most to explore and promote cannabidiol as a legitimate therapeutic agent. And they were able to do so because they, unlike most federally licensed medical researchers, had access to the whole plant.

    We’ve been down this road before. Not long ago, lawmakers and anti-marijuana zealots were dismissing patients’ desire to access the marijuana plant because they alleged that the THC-pill Marinol could adequately meet patients’ needs. Patients and their advocates were skeptical of lawmakers’ claims then, and properly so. Now many of these same politicians are once again dismissing patients’ calls for whole plant medicine by claiming that products and strains containing CBD alone only will suffice. Patients and their advocates ought to be equally skeptical once again.

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