Cannabis, CBD & Low THC Oil Update
Where are we one year later in both Georgia, other states, and on a federal level regarding the use of medical cannabis, CBD and Low THC Oil?
Haleigh's Hope Act, signed into law on April 16, 2015 in the state of Georgia, legalized the possession of up to 20 ounces of cannabis oil with no more than 5% THC for patients with one of eight qualifying conditions, including mitochondrial disease.
Despite the passage of comprehensive medical marijuana programs now in 23 states, the district of Columbia and Guam, and the enactment of limited access marijuana laws in 17 states, including Georgia, cannabis remains a schedule one substance and therefore illegal despite an attempt by congressman Steve Cohen of Tennessee to address the use of medical cannabis on a federal level in the CARERS Act of 2015 submitted last year in the House of Representatives. His proposed bill would allow states to legalize marijuana for medical use without federal interference, permit interstate commerce of CBD oils, reschedule marijuana to a schedule two substance, allow banks to provide checking accounts and another financial services to marijuana dispensaries, allow VA physicians to recommend medical marijuana to vets, and eliminate barriers to medical research.
Because no changes have occurred in the federal laws governing medical cannabis and its use, patients in states with restricted programs can only acquire cannabis out-of-state potentially risking prosecution by the DEA if that agency elects to enforce federal statutes. Although patients in states with comprehensive programs fare better, they still face risks of federal prosecution if they are found transporting cannabis products between state lines.
In Georgia, we are attempting to expand on Haleigh's Hope with HB722 submitted earlier this year into the Georgia House of Representatives by state representative Allen Peake. The bill provides for the in-state cultivation and distribution of cannabis products by July 1, 2017 and expands condition coverage to include autism, AIDS, glaucoma, Alzheimer's, terminal illness, intractable pain (defined differently and more stringent than chronic pain), PTSD and several other illnesses and disorders. Although this expansion is supported by 84% of Georgians, our current governor, Nathan Deal, is opposed to the bill despite stringent restrictions in the proposed law that would regulate the cultivation and distribution of cannabis products in Georgia to include limiting licensees for cannabis production to between 2-6 providers, require that all products are certified by a third-party lab, and limit the distribution of cannabis products through licensed pharmacies only. Additional restrictions would prohibit smoking cannabis products with use of liquid, pill or oil substances only and implement tougher criminal penalties for violation of the law.
Unfortunately, sources close to the process indicate that they are facing a challenging, uphill battle in our state but remain hopeful that the law will ultimately be passed.
One year ago, we had the extreme pleasure of authorizing the very first card for the use of high CBD low THC oil in the state. Since that time, we have provided cards to 16 patients. Because state law requires that the card allowing legal possession of medical cannabis be renewed yearly and that we as registering physicians must complete and upload quarterly reports to the Georgia Department of Public health, we have accumulated data on our patient's use of and response to therapy.
Although one patient with pervasive developmental delay developed muscle twitching after use of the oil and another adult with activity intolerance, muscle stiffness and pain reported no significant improvements with cannabis therapy, most patients have shown some benefits to this therapeutic intervention.
For example, one patient with Leigh disease and seizures has noted a marked improvement in seizure control, pain relief and increased G.I. functionality. Another with a myopathy has less muscle and nerve pain on the oil and a teenager with autism and seizures has had no seizure activity since starting cannabis. A young girl, also with autism as a component of her mitochondrial disease, has shown a decrease in stimming behaviors, and increased alertness with more attempts at verbal communication while an almost 5-year-old with global developmental delays began speaking following institution of cannabis oil.
Although several patients elected not to institute therapy after obtaining the cannabis card, and several reported either no improvements or minor adverse responses, most patients reported positive outcomes following institution of medical cannabis therapy.
Aside from our own personal experience, a number of studies have now shown the benefits of medical cannabis. Reported at the American Academy of Neurology meeting in April 2015, one group evaluated 213 adults and children with 12 different forms of severe epilepsy including Dravet syndrome and Lennox-Gastaut treating them for 12 weeks with daily CBD. A total of 137 patients completed the study with a 54% reduction in seizure activity overall while 10% of the patient population became seizure free. Of the 12 patients who discontinued cannabis therapy, 21% cited drowsiness, 17% diarrhea, 17% fatigue, and 16% decreased appetite as the primary causes for discontinuing treatment. Several other studies have found similar data supporting a positive response to therapy.
On a cellular level, a German group suggested that exposure to cannabis may improve mitochondrial function in rodent models. They state that the activation of the brain's cannabinoid systems triggers the release of antioxidants and may eliminate the brain inflammation seen with a number of Neurodegenerative disorders, potentially including mitochondrial disease.
In an article published in 2014 in JAMA Internal Medicine, a group of researchers postulated another added benefit of medical cannabis citing that its use for chronic pain may reduce the rising opioid analgesic overdose mortality seen in the US. They noted that three states had medical cannabis laws effective prior to 1999 to include California, Oregon and Washington and 10 states enacted medical cannabis laws between 1999 and 2010. By analyzing death certificate data compiled by the CDC, they determined that states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate compared to states without similar laws. In addition, the data shows that the reduction in mortality per state increases every year after passage of the medical cannabis law typically reaching 34% after five years of legalization.
Clearly, our personal data, and research surrounding the use of medical cannabis has provided a number of positive indicators of its use to date.
The medical cannabis laws in the United States are evolving but there continues to be considerable federal and state level obstacles preventing the creation of a unifying, consensus-based agreement on enacting legislation allowing more widespread usage and access for patients.
Our personal experience over the past year correlates well with other reports in regards to improvement in seizure management although we are seeing a multitude of additional benefits from its use in our specific patient population.
Ongoing state and federal regulations and advocacy are required to expand and increase the usage of this seemingly quite beneficial compound in treating a multitude of problems for a wide spectrum of patients, including those with mitochondrial disease.
Fran Kendall, M.D.
Founder, Managing Director of VMP Genetics, Clinical Biochemical Geneticist
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