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.
Michigan physicians may now authorize cannabis for the treatment of post traumatic stress.
Members of the Medical Marihuana Review Panel voted 6 to 2 to expand the state’s list of qualifying conditions to include PTSD. The Director of the Michigan Department of Licensing and Regulatory Affairs has signed off on the recommendation.
This is the first time that regulators have expanded the state’s list of qualifying conditions since voters initially legalized the physician authorized use of cannabis in 2008.
Six other states — Connecticut, Delaware, Maine, New Mexico, Nevada, and Oregon — explicitly allow for the use of cannabis to treat symptoms of post-traumatic stress. Nevada regulators expanded their law to include PTSD earlier this year. Oregon and Maine lawmakers amended their medical cannabis laws last year to include post-traumatic stress.
California physicians may recommend medical cannabis at their discretion.
Clinical trial data published in the May issue of the journal Molecular Psychiatry theorized that cannabinoid-based therapies would likely comprise the “next generation of evidence-based treatments for PTSD (post-traumatic stress disorder).”
Post-traumatic stress syndrome is an anxiety disorder that is estimated to impact some eight million Americans annually. To date, there are no pharmaceutical treatments specifically designed or approved to target symptoms of PTSD.
Last week, federal officials at the Public Health Service approved the use of cannabis in a privately funded pilot trial at the University of Arizona College of Medicine to assess its potential risks and benefits in war veterans suffering from PTSD, including the plant’s potential impact on subjects’ anxiety, suicidality, and depression. Although the study was initially approved by the FDA in 2011, neither PHS nor the US National Institute on Drug Abuse (NIDA) signed off on the protocol until this month. Both agencies, as well as the US DEA, must approve any clinical trial involving cannabis.
Retail sales of cannabis in the month of January yielded an estimated $3.5 million dollars in state tax revenues, according to financial data released online this week by the Colorado Department of Revenue.
Under Colorado law, commercial cannabis producers must pay a 15 percent excise tax, while retail customers must pay an additional ten percent sales tax (on top of the state’s existing 2.9 percent sales tax) on any cannabis purchased at a licensed facility. The majority of Colorado voters approved the imposition of cannabis-specific taxes (Proposition AA) in November 2013.
For the month, customers spent an estimated $14 million on the purchase of marijuana and cannabis-infused goods at state-licensed facilities. This figure is anticipated to grow larger as more and more facilities become operational.
State law authorized the retail sale of cannabis beginning on January 1st to those age 21 or older. At that time, only 24 retailers were operational. By month’s end, nearly 60 facilities were up and running. Presently, over 150 licensed facilities are operational.
Similarly licensed retail operations are anticipated to be operational in Washington by this summer.
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.