Increasing Access To Medical Nutrition Therapy As Treatment For Epilepsy

Abstract

Epilepsy is the most common neurological disorder among children and the fourth most common neurological disorder overall in the United States. In 2015 there were approximately 3.4 million people diagnosed with epilepsy nationwide: 3 million adults and 470,000 children. The overall cost of epilepsy in the United States is estimated to be $15.5 billion yearly (Centers for Disease and Prevention [CDC], 2017). It is a broadening national concern acutely lacking the resources and attention necessary to reverse the condition’s effects. Epilepsy is a condition defined as having two or more seizures occurring in a twenty-four-hour period. Seizures occur when nerve cells signal irregularly which may manifest as strange sensations, emotions, behavior, and in many cases convulsions or a loss of consciousness (Williams, 2015).

Medical Nutrition Therapy is a widely accepted practice for treating epilepsy and seizure disorders by specifically tailoring their diet to treat associated symptoms— often implemented, and prescribed, by their physician and appointed dietician. The main stakeholders are medical professionals, primary care providers, insurance providers, health maintenance organization, patients and their respective families. Three different proposed strategies to increase access to treatment were analyzed.

Problem Statement & Background

A perplexing and often misunderstood condition—epilepsy is a neurological disorder associated with abnormal electrical activity in the brain which often results in temporary interference of mental, sensory, or motor functions. The recurrent, sudden episodes of disturbance are referred to as seizures; consequently, the various states of interference result in different types of seizures. However, seizures are commonly separated into two groups, partial and generalized, according to the clinical characteristics and Electroencephalography (EEG) findings (Williams, 2015). Epilepsy is a globally widespread neurological disorder; affecting approximately 65 million worldwide (CDC, 2017).

Of that population, there is a total of over 3 million citizens in the United States living with epilepsy surpassing the population affected by autism spectrum disorder, cerebral palsy, multiple sclerosis, and Parkinson’s disease combined (“The Epilepsy Network”, n.d.). In fact, The Epilepsy Foundation cites there are roughly 200,000 new cases of epilepsy and seizure disorders diagnosed each year and 45,000 children diagnosed annually as well (2011); which according to Susan G. Komen for the Cure, rivals the number of first-time breast cancer patients diagnosed annually (Smith, 2011).

The effects of epilepsy contend with those of breast cancer in both extent and consequence claiming as many lives annually in the United States. Upwards of 50,000 Americans die each year from seizures and seizure related causes: such as Sudden Unexplained Death in Epilepsy (SUDEP), trauma, drowning, choking, etc. According to a study published in the New England Journal of Medicine, findings showed that patients who developed childhood epilepsy had a substantially higher death rate if their seizures were not controlled over a five-year period (2010).

Some estimates state that the mortality rate for people diagnosed with epilepsy is two to three times greater, and the risk of sudden death is twenty-four times higher, than that of the general population (Meacham, 2009). Regrettably, epilepsy does not receive the notorious public support that breast cancer and many other conditions to on national, or even global, platforms. Professional sports players, television personalities, and entertainers regularly brandish their pink attire and ribbons to support awareness for breast cancer while epilepsy lingers in the relative anonymity while affecting just as many lives.

Epileptics live in fear on a daily basis being continually haunted by the unremitting reality that a seizure could occur at any moment. The effectiveness of treating patients suffering from epilepsy utilizing a ketogenic diet, in a clinical setting, under the supervision of a health professional have been observed and well documented. The ketogenic diet has been used since the 1920’s to treat seizure disorders (Wheless, 2008). Ketogenic diet functions by transitioning the body to metabolize fat as fuel as opposed to a state of glycolysis where blood glucose provides the body with energy. The metabolic state of ketosis is an effective means of providing the brain with an alternate source of fuel—ketone bodies. There are also anti-seizure properties associated with the switching of brain cell’s metabolism from glucose to ketones (Rho, 2017).

Epilepsy not only trails in terms of awareness, but also lags behind in terms of allocated resources and funding. The federal government utilizes significantly less resources in support of epilepsy treatment compared to other neurological and chronic illnesses. The National Institute of Health (NIH) spends $30 billion on medical research; yet only half of one percent,.5 percent, is spent on Epilepsy research (“What is Pediatric Epilepsy”, n.d.). Public and private funding for research of epilepsy provides less than a quarter of the budget granted for other neurological disorders and diseases.

For instance, $35 is allocated from the budget per epilepsy patient while over three times that amount $129 for Alzheimer’s patients, and eight times as much, $280 is allocated per multiple sclerosis patient (Meacham, 2009). According to the article published in 2017, “Where’s The Funding? Epilepsy As An Orphan”, pharmaceutical investment is less than both Alzheimer’s and Parkinson’s disease combined. In addition, it is expected to decline even further of the next few years (Johnson, 2017). In addition, epilepsy researchers receive nearly 50 percent less funding than their counterparts studying other neurological disorders or diseases. Per patient and in total, epilepsy is severely underfunded by the government, pharmaceutical companies, and even private organizations.

The National Institute of Health (NIH) estimates that about 70 percent of those diagnosed with the affliction can control their seizures with anti-epileptic drugs and in some cases surgery. However, the remainder of approximately 30 percent remains refractory to the anti-epileptic drug treatment—despite the development of newer medications. Patients with anti-epileptic drug resistance account for most of the burden of epilepsy among the population and healthcare system (Laxer et al., 2014).

Adverse effects of anti-epileptic drugs are commonly experienced by epileptics; causing the comorbidity of anxiety and depression often resulting in considerable impact on their quality of life and in some cases treatment failure in up to 40 percent of patients (Perucca & Meador, 2005). Epileptic treatment has historically centered around the medicinal approach of drug administration as the cure. This unilateral approach is to blame for the large percentage of those left untreated and hinders the medical research that could be made by other means.

Ketogenic diets as a form of treatment is a concept that has circulated throughout societies for centuries. The first recorded cases of epilepsy and seizure disorders date back to 500 BC (Wheless, 2008). On The Sacred Disease, written by Hippocrates, is regarded as one of the first documented cases of epilepsy. In the literature Hippocrates noted that the brain was the cause of the affliction and that the administration of food aggravated the seizure symptoms (Adams, 2009). Furthermore, he noted that the abstinence from food could cure the individual of seizures—which is most likely attributable to a metabolic state of ketosis achieved due to carbohydrate restriction via fasting.

The application of a diet high in healthy fats combined with a restriction of carbohydrates has been known by neurologists, for nearly a century, to effectively treat epilepsy and drug resistant epilepsy (Wheless, 2008). A recent study conducted in 2012, involving researchers from Harvard Medical School and Dana-Farber Cancer Institute, linked anti-seizure effects to a specific protein involved in cellular metabolism and ion channels in the brain (Leo). In a Neuroscience Letters publication, titled “How does the ketogenic diet induce anti-seizure effects?”, the author highlights the remarkable effects of ketosis on drug resistant epilepsy (Rho, 2017).

Ketogenic diet therapies are an effective, efficient, and economical alternative to anti-epileptic drugs especially when medications are inefficacious. Past and present research has established a ketosis to be beneficial in reducing and treating seizures in patients with epilepsy—therefore it is pivotal for the advancement of public health to continue research to advance and improve treatment.

Historically, fasting and similar abstinence diets have proven to treat epilepsy and seizure disorders for thousands of years. As captured in literature such as the Hippocratic collection and The King James Version of the Bible (Wheless, 2008). Although, many of the historical assertions made in these documents once seemed outlandish, modern science can now support the benefits seen in the ancient and biblical treatments of seizure disorders to a metabolic state of ketosis. Epilepsia, the Official Journal of the International League Against Epilepsy, published an article titled “History of the Ketogenic diet”. The author, a pediatric neurologist, reviews and analyzes “the history of one of the most effective treatments for childhood epilepsy” (Wheless, 2008).

The first clinical application of fasting or abstinence diets were utilized by physicians over a century ago. Two physicians treated 20 adults & children suffering for epilepsy with a “starvation” diet and noted less severe seizures (Barborka, 1928). In the early twentieth century, medical practitioners at Harvard Medical School were first to note improvement in seizure symptoms after 2-3 days of fasting treatment. One of these physicians documented the effectiveness of seizure control was due to a metabolism shift arising from abstinence of foods and/or carbohydrates.

In the 1920’s, individual lines of inquiry were being made by researchers and physicians across the country regarding the efficacy of fasting as treatment for epileptics. During this time, essential scientific breakthroughs were made. A researching physician noted the presence of two specific compounds—acetone and beta-hydroxybutyric acid—in individuals who were a fasted state or a restricted carbohydrate diet (Woodyatt, 1921). Both acetone and beta-hydroxybutyric acid are ketone bodies. Concurrently, physicians across the country at the Mayo Clinic were designing diets to obtain the benefits of fasting as treatment for a more sustainable practice.

Medical practitioners recorded calculations of macronutrient quantities that are identical to what are used today; for instance, “1 gram of protein per kilogram of body weight, 10-15 grams of carbohydrate per day, and the remainder of the calories in fat” (Peterman, 1925). Dr. Livingston, at Johns Hopkins Hospital, recorded the results of treating over 1,000 children with epilepsy over decades. The findings of each research case not only verified historical usage of ketogenic/abstinence diets, but began a correlative body of data supported by empirical research that would build the foundation for ketogenic diet therapy as a valid method of treatment. Dr. Livingston reported 52 percent had complete seizure control and an additional 27 percent had improved control of their symptoms (Wheless, 2008).

Due to the advent of anti-epileptic drugs in 1938, when Merritt and Putnam discovered diphenylhydantoin, the focus of research shifted to new anti-epileptic pharmaceutical treatment alternatives (Friedlander, 1986). As new anti-epileptic drugs became available there was a decline in the use of ketogenic diet therapies. The development of anti-epileptic drugs such as sodium valproate, a branched-chain fatty acid with anticonvulsant properties, were designed to treat children previously on the diet (Wheless, 2008). Ultimately the result was: a significant shortage of trained health professionals in ketogenic diet therapies, lack of research & data, incorrect implementation of a ketogenic diet, and eventually a flawed perception of the diet’s effectiveness. The decrease in prevalence of the ketogenic diet as treatment is made evident when looking at the PubMed publications; from 1970 to 2000 there was only 2 to 8 publications per year (Wheless, 2008). Medical research regarding epilepsy began to solely focus on pharmaceutical discoveries as treatment rather than focusing on the continued success ketogenic diets had once shown.

Studies conducted in the recent decade are still linking different aspects of the ketogenic diet to antiepileptic effects. One study recently published reported that ketogenic diets enhance overall bioenergetics and reduces oxidative stress (Rho, 2017). The same study mentions that clinical and experimental interests of the ketogenic diet are expanding. Ketogenic diets have historically been proven to be a capable cure for many patients, and, at any expense, an avenue of research worthy of continued pursuit. At the least, it offers a practical solution for many patients who can find no relief through the usage of anti-epileptic drugs or widely used other methods of treatment.

Policy Landscape

The main stakeholders are medical professionals, primary care providers, insurance providers, health maintenance organization, patients and their respective families. Many of the physicians whom operate as primary care providers are hesitant and ill-informed when it comes to prescribing Medical Nutrition Therapy and ketogenic diet as a primary means of treatment. However, there are a growing number of progressive medical practitioners and clinics that are utilizing MNT and KD as a therapeutic treatment. In addition, the pharmaceutical industry is a concerned party due to possible loss in revenue. Economic issues will inevitably rise regarding decline of pharmaceutical medication prescriptions of anti-epileptic drugs.

Policy Options

Increasing access to Medical Nutrition Therapy as a treatment for epilepsy is imperative for improving healthcare coverage and Public Health among the population. The initiatives to increase access to Medical Nutrition Therapy as a treatment for epilepsy needs to be multi-leveled in order to reach the most patients effectively.

The first policy change needs to be focused on changing insurance policies criteria & guidelines to cover Medical Nutrition Therapy and reduce numbers of denials due to prior authorizations. The initiative at this level is crucial to reach patients in immediate need of coverage.

The second policy recommendation needs to be focused on requiring healthcare provider and facility education programs to expand and encourage Medical Nutrition Therapy treatment utilizing ketogenic diet. This focus is imperative for allowing patients and family full access to available treatments.

The third policy is to promote patient education about the benefits and risks of ketogenic therapy in epilepsy treatment and encourage programs in healthcare facilities and clinics. The final initiative is on the level of patient advocacy groups and informational pamphlets. By encouraging patients to read up and educate themselves on treatment options it allows for a better conversation between provider and patients; ultimately limiting misinformed decisions and lack of knowledge of treatment options.

Policy Recommendations

The first policy to be analyzed is, theoretically, the initial strategy that should be implemented and it begins on a state level with specific insurance care providers and their corresponding healthcare facilities. Many of the stakeholders are proponents of accessing this type of care in the hospital and clinic setting and increasing accessibility for patients in dire need of care.