By Philip M. Gattone, President & CEO, Epilepsy Foundation, and
Warren Lammert, Chair, Epilepsy Foundation Board of Directors
With Commentary from Orrin Devinsky, M.D., Professor of Neurology, Neurosurgery and Psychiatry, Director, NYU Comprehensive Epilepsy Center Member of Epilepsy Foundation National Board of Directors
As parents and as advocates, we feel an urgency to respond and take action on an issue that has been brought to the Epilepsy Foundation from individuals we serve across the country-- the use of marijuana to treat epilepsy. We write this with advice and support from Nathan Fountain, Chairman of our Professional Advisory Board, and with advice and support from a range of other leading epilepsy professionals and board members.
2.3 million Americans live with epilepsy, a neurological condition that includes recurring seizures. More than 1 million of them live with uncontrolled seizures. Some of these people may be helped by surgery or other non-drug treatments, but for many, no answers have been found yet. People with uncontrolled seizures live with the continual risk of serious injuries and loss of life.
The Epilepsy Foundation supports the rights of patients and families living with seizures and epilepsy to access physician directed care, including medical marijuana. Nothing should stand in the way of patients gaining access to potentially life-saving treatment. If a patient and their healthcare professionals feel that the potential benefits of medical marijuana for uncontrolled epilepsy outweigh the risks, then families need to have that legal option now -- not in five years or ten years. For people living with severe uncontrolled epilepsy, time is not on their side. This is a very important, difficult, and personal decision that should be made by a patient and family working with their healthcare team.
Treatments for epilepsy with any form of marijuana come with risks, as there is much that is not known about its effects. The consistency of available formulations also needs to be addressed. Caution is appropriate, and we strongly recommend that patients with uncontrolled seizures seek out an epilepsy specialist. However, existing therapies have real side-effects both known and unknown, and, just as there are risks with any treatment, every day without seizure control is a risk to life. Every seizure is a possible opportunity lost to live, learn, and grow.
The Epilepsy Foundation calls for an end to Drug Enforcement Administration (DEA) restrictions that limit clinical trials and research into medical marijuana for epilepsy. We applaud recent decisions that have allowed clinical trials of Cannabidiol (CBD) oil, to begin in several states. Certain components of medical marijuana, including CBD, have shown effectiveness in animal studies, and there have been encouraging anecdotal reports from patients. But further research and unbiased clinical trials are needed to establish whether and in what forms medical marijuana is or is not effective and safe. Restrictions on the use of medical marijuana continue to stand in the way of this research.
The Epilepsy Foundation believes that an end to seizures should not be determined by one’s zip code. Our current situation as an epilepsy community is not acceptable. Families looking to access medical marijuana as a treatment are facing terrible decisions. One parent may move across the country to live with a child to seek this treatment. Other families may uproot entirely, including leaving their job, to move where they can access CBD oil. In the past, when therapies not yet approved by the Food and Drug Administration (FDA) were available abroad and left only to those who could afford to travel, we fought for compassionate access. We are here to continue the fight.
The Epilepsy Foundation will be doing the following to support improved access and research into medical marijuana:
- Calling on the Drug Enforcement Administration to implement a lesser schedule for marijuana so that it can be more easily accessible for medical research.
- Supporting appropriate changes to state laws to increase access to medical marijuana as a treatment option for epilepsy, including pediatric use as supported by a treating physician.
- Supporting the inclusion of epilepsy as a condition that uses medical marijuana as a treatment option where it is currently available.
- Supporting research on multiple forms of cannabis and seizures.
What can you do to help? Advocate for increased access and for the freedom to conduct medical research on a potentially effective treatment against seizures and epilepsy. Join with us at http://capwiz.com/efa/mlm/signup.
Here’s Our Story:
As the President & CEO and as the Chair of the Board of the Epilepsy Foundation, we are privileged to lead a nationwide network of caring volunteers and staff who work tirelessly to improve lives of individuals living with epilepsy.
We are also fathers of individuals living with epilepsy. Phil’s son has had thousands of seizures in his life and has endured two brain surgeries to stop his seizures. Warren’s daughter has a genetic form of epilepsy that is marked by severe seizures and, despite an implanted medical device and three different epilepsy medicines, endures daily waves of seizures.
Some individuals, specifically families of children with uncontrolled seizures, are using what is called cannabidiol oil, or CBD oil, and anecdotally a few are seeing remarkable results. This is truly spectacular -- anytime someone finds a treatment that stops seizures, there is cause for celebration because seizure freedom for one person means hope of seizure freedom for others.
There is still a lot we don’t know about the medical use of marijuana for epilepsy. Until clinical trials are completed, doctors and patients will not know whether medical marijuana or CBD will on balance harm someone or help someone with epilepsy. We are advocating for the rights of patients and families to determine with their doctor if this is an appropriate therapy for them, but we recognize the unknowns and the difficulty of this decision for an individual patient.
There is an obvious and urgent need for research. The Epilepsy Foundation is proud that we are currently funding an important research study to learn more about the effect of a form of cannabis on individuals living with uncontrolled epilepsy.
As fathers, we know the pain of watching our children experience uncontrolled seizures.
We know how epilepsy impacts development in children for whom no available current treatment has been successful.
We know about the dangers that can occur when families are forced to leave medical systems and physicians they know to move to other states.
We know seizures not only affect the individual enduring seizures, it also impacts siblings, parents, grandparents, kids and grandchildren, other loved ones and friends.
We know the difference between having recurring seizures and not having seizures can mean the difference between life and death.
Warren’s daughter is fortunate to be enrolled in a clinical trial of CBD. We do not know if this will help Sylvie but know the cost of her unrelenting seizures. Weighing the issue with her doctor, we decided the potential benefits outweigh the risks. Other parents and other individuals living with potentially devastating seizures should have the same opportunity to make that determination.
If an epilepsy patient and their doctor feel that marijuana is their best treatment option then they need to have safe, legal access to medical marijuana and they need that access now.
Medical Marijuana: We Need Proof and Compassion
Orrin Devinsky, M.D., Professor of Neurology, Neurosurgery and Psychiatry, Director, NYU Comprehensive Epilepsy Center; Member of Epilepsy Foundation National Board of Directors
There is an enormous unmet need for better treatments for children and adults with epilepsy. Approximately one-third of people with epilepsy continue to suffer from seizures despite the best medical, dietary, and surgical therapies. For those with treatment-resistant epilepsy, the enormous toll includes the direct and potentially deadly consequences of the seizures, which are compounded by the disabling physical, cognitive and behavioral side effects from high doses of multiple antiepileptic drugs. Despite advances in epilepsy therapy over the past decades, our progress remains painfully slow and disappointing. Medical care and research fails many patients. The statement by Phil Gattone and Warren Lammert of the Epilepsy Foundation strongly advocates that there should be legal access for all epilepsy patients and their doctors who feel that marijuana is their best treatment option. I agree.
In a recent Op-Ed piece in the New York Times, my colleague Daniel Friedman and I emphasized 1) the need for randomized controlled trials, considered the gold standard for clinical trials, to better understand the safety and effectiveness of any drug or combination of drugs – whether derived from a marijuana plant or synthesized in a lab, 2) the need for changes in how the Drug Enforcement Agency classifies marijuana and its constituents as Schedule 1 drugs. This is much too restrictive based on the scientific data, especially for cannabidiol (CBD) – the major non-psychoactive component of marijuana, and 3) while we await scientific studies, that marijuana products be made available to pediatric and adult patients with treatment-resistant epilepsy.
Charlotte Figi, who has brought this story to the forefront, suffers from Dravet Syndrome, a genetic disorder that often causes severe epilepsy. Medical marijuana, high in CBD and low in THC, has been reported to cause a dramatic reduction in her seizures and eliminate her need for seizure medications. Caring for epilepsy patients for 25 years, I have seen firsthand the devastation that uncontrolled epilepsy can bring. In the last 2 years, two of my patients with Dravet Syndrome died from sudden unexpected death in epilepsy (SUDEP).
Data from animal studies showing CBD and THC can stop seizures, stories like Charlotte’s, and the tremendous unmet need led me to organize the first international symposium on cannabidiol for epilepsy at NYU in October 2013, to provide testimony for compassionate use for marijuana to several state legislatures, and to work as a researcher (without consulting fees or salary support) to assess CBD as an epilepsy therapy. For our initial study for 25 pediatric and young adult patients, we have received inquiries from more than 500 families and patients.
We stand at an unusual inflection point where families are demanding access to a medication that may or may not be beneficial, and for which the side effects may be less than many medications prescribed by doctors; the medical community lacks convincing efficacy or safety data for children with epilepsy; and the Drug Enforcement Agency’s overly conservative scheduling of marijuana hamstrings research and access. Yet there should be caution for both expectations and potential side effects. Humility is essential in trying to understand something for which we lack solid evidence. Both doctors and patients are equally biased and the greater the expectation, the greater the potential for bias. We urgently need data from randomized controlled trials where the biases of companies, doctors, patients, and parents are meticulously removed.
We need to make a balanced decision about compassionate use. If I were Charlotte Figi’s parents and lived in Colorado I would have done exactly what they did. And as a doctor, I would gladly prescribe marijuana products for many of my patients who failed existing therapies if it were legal in my state. Trying marijuana or related compounds should be regarded like any other experimental treatment – a shared decision between patient/parent and doctor, that takes into account the severity of disease, risk and benefits of treatment, and existence of alternate treatment options, all guided by the principle of "first do no harm”. Until we have the scientific data, we should make medical marijuana available to physicians who care for people with treatment-resistant epilepsy and their patients.