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.
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.
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.
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.
#1 Public Support For Legalizing Marijuana Hits Historic Highs
An unprecedented 58 percent of Americans believe that marijuana ought to be “made legal” for adult consumption, according to survey data reported in October by Gallup. The percentage is the highest level of support ever recorded by Gallup, which has been inquiring on the issue since 1969, and marks a ten percent increase in voter approval since 2012. Regional polls conducted this year in several states, including California, Louisiana, and Texas, also reported majority support for legalization.
#2 Nation Of Uruguay Passes Legislation Regulating Cannabis Use
Lawmakers in the South American nation of Uruguay enacted legislation authorizing the licensed production and retail sale of cannabis to all citizens age 18 and older. Residents will be able to legally purchase up to 40 grams of cannabis per month from state-licensed stores at a price of $1 per gram. Uruguay is the first country in modern history to officially legalize and regulate the licensed production and retail sale of cannabis.
#3 Feds Pledge Not To Interfere In State-Licensed Retail Sales Of Cannabis
Deputy Attorney General James Cole issued a three-page memorandum in August affirming that the US Justice Department will allow Colorado and Washington to move forward with statewide efforts to license and regulate the adult marijuana market. Cole later reaffirmed the agency’s position in testimony before the US Senate, stating, “We will not … seek to preempt state ballot initiatives.”
#4 States Finalize Regulations Governing Adult Cannabis Sales
Regulators in Colorado and Washington this fall began accepting applications from businesses seeking to engage in the licensed cultivation, production, and retail sale of cannabis and cannabis-infused products. In Washington, several thousand applicants have applied to pot business licenses. In Colorado, regulators have begun approving licenses and several commercial establishments are expected to be open for business on January 1, 2014.
#5 Record Number Of Statewide Marijuana Reform Measures Enacted Into Law
Lawmakers in a dozen states approved some 20 pieces of marijuana law reform legislation in 2013. Specifically, lawmakers in Colorado and Vermont enacted legislation licensing commercial hemp production; Illinois and New Hampshire legalized the use and distribution of marijuana for medical purposes; Oregon and Nevada approved regulations allowing for the establishment of medical cannabis distribution facilities; and Oregon and Vermont significantly reduced marijuana possession penalties.
#6 Cannabis Dispensaries Open In Washington, DC
Medical cannabis facilities opened for business in Washington, DC in 2013. The establishments are licensed and regulated by the District of Columbia, which finally unveiled its long-awaited medical marijuana program earlier this year. State-authorized dispensaries also opened for the first time this year in New Jersey, Rhode Island, and Vermont. Lawmakers in four states, Illinois, Oregon, Nevada and New Hampshire, enacted legislation in 2013 allowing for the establishment of medicinal cannabis facilities.
#7 Study: Blacks Arrested For Pot Offenses At Rates Four Times That Of Whites
African Americans are far more likely to be arrested for marijuana possession offenses than are whites, according to an American Civil Liberties Union (ACLU) report released in June that analyzed arrest data from 945 counties nationwide. The report found that blacks were approximately four times as likely as whites to be arrested for marijuana possession in 2010, even though both ethnicities consumed the substance at similar rates. Authors reported that the racial disparity in arrest rates had grown significantly over the past decade and that in some states African Americans were nearly eight times as likely as whites to be arrested for cannabis possession.
#8 FDA Approves Clinical Trials Of CBD In Cases Of Pediatric Epilepsy
The US Food and Drug Administration this fall granted approval for the importation of cannabidiol (CBD) extracts as an experimental treatment for a rare, intractable form of pediatric epilepsy known as Dravet syndrome. Preliminary clinical trials assessing the safety and tolerability of the compound in children are scheduled to begin in early 2014. Cannabidiol is a non-psychoactive cannabinoid that has been documented to possess a variety of therapeutic qualities, including anti-inflammatory, anti-diabetic, anti-epileptic, anti-cancer, and bone-stimulating properties.
#9 Study: No Association Between Cannabis Smoking And Lung Cancer
Subjects who regularly inhale cannabis smoke possess no greater risk of lung cancer than do those who consume it occasionally or not at all, according to data presented in May at the annual meeting of the American Academy for Cancer Research. UCLA investigators analyzed data from six case-control studies, conducted between 1999 and 2012, involving over 5,000 subjects (2,159 cases and 2,985 controls). They reported, “Our pooled results showed no significant association between the intensity, duration, or cumulative consumption of cannabis smoke and the risk of lung cancer overall or in never smokers.”
#10 Members Of Congress Introduce Legislation To End Federal Pot Prohibition
Members of Congress in February introduced historic legislation, HR 499: The Ending Federal Marijuana Prohibition Act, to remove cannabis from the control of the Drug Enforcement Administration and authorize the US Department of Treasury to license state-authorized retail marijuana producers and distributors. Although Congress refused to vote on the measure in 2013, it was the most-viewed legislation on the Congress.gov website.