Alabama's High-CBD Seizure Disorder Treatment Bill Contains Technical and Practical Flaws

March 24, 2014 | Mike Liszewski

Note: updated 3.25.14

Last week Alabama passed SB 174, also known as Carly's Law, which is designed to create limited access to high-CBD cannabis preparations. While this bill can be viewed a some measure of progress to come out of the part of the country that that traditionally has been the least receptive to medical cannabis, the bill contains substantial problems that will prevent Alabama many patients from benefiting from it.

The bill differs from other successfully implemented medical cannabis laws in many ways. While every other medical cannabis bill in the country allows access to a number of conditions, SB 174 only creates legal access for patients with seizure disorders who have been diagnosed by the University of Alabama-Birmingham's (UAB) Department of Neurology. Some have said this is a "CBD-only" bill, but it does in fact allow for up to 3% THC in the preparations. The bill does not protect patients, caregivers, and UAB healthcare workers from arrest, but instead offers them an affirmative defense. Wisely, the bill does explicitly prohibit a state agency from removing the child custody rights from a parent who has enrolled their child in the UAB program. It appears the UAB would be the source of the high-CBD preparations, but it is not clear how UAB would obtain or produce it, but it is clear that the medicine can not be in its original plant form. Lastly, it requires that all patients obtain a "prescription" for the high CBD-preparations from the UAB.

The word "prescription" is key here, as no licensed medical physician in the United States may write a prescription for medical cannabis without violating federal. Physicians may not write prescriptions for substances found in Schedule I of the Federal Controlled Substances Act. Unless the FDA approves the type of high-CBD preparations that the bill intends to make available, or the federal government reschedules cannabis to at least II or lower, no UAB medical staff will be able to provide such prescriptions. Arizona encountered the problem with their 1998 law, but it appears that history has repeated itself. Instead, successful medical cannabis laws use the term "recommendation," as physicians have a protected free speech right to recommend medical cannabis. 

Furthermore, distributing cannabis, is something that hospitals or universities that receive federal accreditation or funding will not likely risk to run such a program, even for high-CBD preparations. As ASA predicted, Maryland recently learned this lesson with its current hospital-based approach, which has shown to be a technical impossibility to implement, as no hospitals have been able to seriously consider participating in the program. As a result, Maryland is currently working on legislation that would bring a more traditional and functional medical cannabis program to the state.

These issues will likely mean that Carly's Law will have to be significantly amended in order for it to work even for those patients living with the single qualifying condition it would treat. Clean up legislation next year will have to strike the prescription language, and allow for 3rd-parties to be licensed by the state to grow, process, and sell medical cannabis, along with independent testing labs to ensure that patients are only obtaining high quality medicine free of potentially harmful contaminants like mold or pesticides that are toxic to humans. Patients deserve protection from arrest and civil discrimination in the areas of housing, employment, and organ transplants. The bill should also seek to include more people who can benefit from medical cannabis therapy by allowing all licensed physicians in Alabama to write recommendations for any condition for why they feel a patient could receive benefit. This is the case for all prescription drugs, even those with the potential for fatal overdose, something that is not possible with medical cannabis therapy.

Alabama's SB174 is certainly a step in the right direction, but the state needs to take several more steps before this bill can help even the limited patient population it is designed to help. Instead of reinventing the wheel, Alabama ought to take into account the experience and best practices learned in other states, and pass compassionate legislation that will serve all of those patients in Alabama who could benefit from medical cannabis therapy.

Update (3.25.14, 8:50 a.m. EDT): It has been pointed out that the GW Pharmacueticals product Epidiolex may be employed by UAB through this law. The FDA has approved a trial for 150 patients at 6 centers in the US, including the UCSF Benioff Children’s Hospital and the NYU Langone Medical Center. It seems possible that UAB could be one of the other four sites. However, this would appear to provide access to only 25 patients at each of the six approved locations, meaning many Alabama patients who could benefit from medical cannabis products, including many with seizures disorders who could potentially qualify in the law, will not gain access to Epidiolex through this program. Additionally, the study will only research pediatric patients, so adult patients with seizures will not have access. These substantial limitations notwithstanding, it does appear that about two dozen children in Alabama will potentially gain access to some form of medical cannabis if UAB is named as a site for the Epidiolex study.



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